FDA spokesperson Siobhan DeLancey told NutraIngredients-USA.com that the warning was not sparked by any particular adverse events, rather it follows American Academy of Pediatrics (AAP) recommendations published in April.
These found breast-fed and partially breast-fed infants should not consume more than 400IU (international units) of vitamin D per day.
DeLancey emphasized that the warning was not an enforcement action but the potential for enforcement existed if manufacturers failed to alter their products so that it was clear 400IU was the recommended vitamin D maximum.
To this end, the FDA yesterday met with trade groups such as the Council for Responsible Nutrition and Natural Products Association, to urge them to urge their members to comply with the advisory. Letters had also been sent to manufacturers of the products in question.
“As many of these products do not require pre-market approval because they are classified as dietary supplements, we have reached out to the trade groups to help in the effort to make industry aware of this,” DeLancey said.
But no timeframes have been set for compliance.
The right D-ropper
While the warning is centered around the 400IU level, the droppers themselves – and their variations – are highlighted as being problematic.
The fact some droppers hold much more than 400IU of liquid means caregivers need to pay attention so that they are using the “right tool for the job” as Wouter Claerhout, the senior marketing manager in human nutrition and health for vitamin D supplier, DSM noted.
The Food and Drug Administration (FDA) is warning of the potential risk of overdosing infants with liquid vitamin D.
Some liquid vitamin D supplement products on the market come with droppers that could allow parents and caregivers to accidentally give harmful amounts of the vitamin to an infant. These droppers can hold a greater amount of liquid vitamin D than an infant should receive.
“It is important that infants not get more than the recommended daily amount of vitamin D,” says Linda M. Katz, M.D., M.P.H., interim chief medical officer in FDA’s Center for Food Safety and Applied Nutrition. “Parents and caregivers should only use the dropper that comes with the vitamin D supplement purchased.”
Vitamin D promotes calcium absorption in the gut and plays a key role in the development of strong bones. Vitamin D supplements are recommended for some infants—especially those that are breast-fed—because deficiency of this vitamin can lead to bone problems such as thinning, soft, and misshaped bones, as is seen with the condition known as rickets.
However, excessive vitamin D can cause nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.
- Ensure that your infant does not receive more than 400 international units (IUs) of vitamin D a day, which is the daily dose of vitamin D supplement that the American Academy of Pediatrics recommends for breast-fed and partially breast-fed infants.
- Keep the vitamin D supplement product with its original package so that you and other caregivers can follow the instructions. Follow these instructions carefully so that you use the dropper correctly and give the right dose.
- Use only the dropper that comes with the product; it is manufactured specifically for that product. Do not use a dropper from another product.
- Ensure the dropper is marked so that the units of measure are clear and easy to understand. Also make sure that the units of measure correspond to those mentioned in the instructions.
- If you cannot clearly determine the dose of vitamin D delivered by the dropper, talk to a health care professional before giving the supplement to the infant.
- If your infant is being fully or partially fed with infant formula, check with your pediatrician or other health care professional before giving the child vitamin D supplements.
Remember: any type of medication or dietary supplement can have adverse effects and must be taken according to the manufacturer’s directions.
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- 6 Side Effects of Too Much Vitamin D
- Deficiency and toxicity
- 1. Elevated blood levels
- 2. Elevated blood calcium levels
- 3. Nausea, vomiting, and poor appetite
- 4. Stomach pain, constipation, or diarrhea
- 5. Bone loss
- 6. Kidney failure
- The bottom line
- Vitamin A
- Vitamin B1 (thiamine)
- Vitamin B2 (riboflavin)
- Vitamin B6
- Vitamin B12
- Vitamin C
- Vitamin D
- Vitamin E
- Folic acid (folate)
- Vitamin K
- Additional information
- FDA Issues Recommendations for Parents, Industry on Infant Vitamin D Supplements
- Vitamin D, Your Baby, and You
- How do we get vitamin D?
- How do I know if my baby is at risk of vitamin D deficiency?
- How much vitamin D should my baby receive?
- Why do breastfed babies need a vitamin D supplement?
- If I am breastfeeding and I eat foods rich in vitamin D, do I still need to give my baby a supplement?
- Do babies who are formula-fed need extra vitamin D?
- Should pregnant women take vitamin D supplements?
- More information from the CPS:
- Reviewed by the following CPS committees:
6 Side Effects of Too Much Vitamin D
Vitamin D is extremely important for good health.
It plays several roles in keeping your body’s cells healthy and functioning the way they should.
Most people don’t get enough vitamin D, so supplements are common.
However, it’s also possible — although rare — for this vitamin to build up and reach toxic levels in your body.
This article discusses 6 potential side effects of getting excessive amounts of this important vitamin.
Deficiency and toxicity
Vitamin D is involved in calcium absorption, immune function, and protecting bone, muscle, and heart health. It occurs naturally in food and can also be produced by your body when your skin is exposed to sunlight.
Yet, aside from fatty fish, there are few foods rich in vitamin D. What’s more, most people don’t get enough sun exposure to produce adequate vitamin D.
Thus, deficiency is very common. In fact, it’s estimated that about 1 billion people worldwide don’t get enough of this vitamin (1).
Supplements are very common, and both vitamin D2 and vitamin D3 can be taken in supplement form. Vitamin D3 is produced in response to sun exposure and is found in animal products, whereas vitamin D2 occurs in plants.
Vitamin D3 has been found to increase blood levels significantly more than D2. Studies have shown that each additional 100 IU of vitamin D3 you consume per day will raise your blood vitamin D levels by 1 ng/ml (2.5 nmol/l), on average (2, 3).
However, taking extremely high doses of vitamin D3 for long periods may lead to excessive buildup in your body.
Vitamin D intoxication occurs when blood levels rise above 150 ng/ml (375 nmol/l). Because the vitamin is stored in body fat and released into the bloodstream slowly, the effects of toxicity may last for several months after you stop taking supplements (4).
Importantly, toxicity isn’t common and occurs almost exclusively in people who take long-term, high-dose supplements without monitoring their blood levels.
It’s also possible to inadvertently consume too much vitamin D by taking supplements that contain much higher amounts than are listed on the label.
In contrast, you cannot reach dangerously high blood levels through diet and sun exposure alone.
Below are the 6 main side effects of too much vitamin D.
1. Elevated blood levels
Achieving adequate levels of vitamin D in your blood may help boost your immunity and protect you from diseases like osteoporosis and cancer (5).
However, there isn’t agreement on an optimal range for adequate levels.
Although a vitamin D level of 30 ng/ml (75 nmol/l) is typically considered adequate, the Vitamin D Council recommends maintaining levels of 40–80 ng/ml (100–200 nmol/l) and states that anything over 100 ng/ml (250 nmol/l) may be harmful (6, 7).
While an increasing number of people are supplementing with vitamin D, it’s rare to find someone with very high blood levels of this vitamin.
One recent study looked at data from more than 20,000 people over a 10-year period. It found that only 37 people had levels above 100 ng/ml (250 nmol/l). Only one person had true toxicity, at 364 ng/ml (899 nmol/l) (8).
In one case study, a woman had a level of 476 ng/ml (1,171 nmol/l) after taking a supplement that gave her 186,900 IU of vitamin D3 per day for two months (9).
This was a whopping 47 times the generally recommended safe upper limit of 4,000 IU per day.
The woman was admitted to the hospital after she experienced fatigue, forgetfulness, nausea, vomiting, slurred speech, and other symptoms (9).
Although only extremely large doses can cause toxicity so rapidly, even strong supporters of these supplements recommend an upper limit of 10,000 IU per day (3).
Summary Vitamin D levels greater than 100 ng/ml (250 nmol/l) are considered potentially harmful. Toxicity symptoms have been reported at extremely high blood levels resulting from megadoses.
2. Elevated blood calcium levels
Vitamin D helps your body absorb calcium from the food you eat. In fact, this is one of its most important roles.
However, if vitamin D intake is excessive, blood calcium may reach levels that can cause unpleasant and potentially dangerous symptoms.
Symptoms of hypercalcemia, or high blood calcium levels, include:
- digestive distress, such as vomiting, nausea, and stomach pain
- fatigue, dizziness, and confusion
- excessive thirst
- frequent urination
The normal range of blood calcium is 8.5–10.2 mg/dl (2.1–2.5 mmol/l).
In one case study, an older man with dementia who received 50,000 IU of vitamin D daily for 6 months was repeatedly hospitalized with symptoms related to high calcium levels (10).
In another, two men took improperly labeled vitamin D supplements, leading to blood calcium levels of 13.2–15 mg/dl (3.3–3.7 mmol/l). What’s more, it took a year for their levels to normalize after they stopped taking the supplements (11).
Summary Taking too much vitamin D may result in excessive absorption of calcium, which can cause several potentially dangerous symptoms.
3. Nausea, vomiting, and poor appetite
Many side effects of too much vitamin D are related to excessive calcium in the blood.
These include nausea, vomiting, and poor appetite.
However, these symptoms don’t occur in everyone with elevated calcium levels.
One study followed 10 people who had developed excessive calcium levels after they had taken high-dose vitamin D to correct deficiency.
Four of them experienced nausea and vomiting, and three of them had a loss of appetite (12).
Similar responses to vitamin D megadoses have been reported in other studies. One woman experienced nausea and weight loss after taking a supplement that was found to contain 78 times more vitamin D than stated on the label (13, 14).
Importantly, these symptoms occurred in response to extremely high doses of vitamin D3, which led to calcium levels greater than 12 mg/dl (3.0 mmol/l).
Summary In some people, high-dose vitamin D therapy has been found to cause nausea, vomiting, and lack of appetite due to high blood calcium levels.
4. Stomach pain, constipation, or diarrhea
Stomach pain, constipation, and diarrhea are common digestive complaints that are often related to food intolerances or irritable bowel syndrome.
However, they can also be a sign of elevated calcium levels caused by vitamin D intoxication (15).
These symptoms may occur in those receiving high doses of vitamin D to correct deficiency. As with other symptoms, response appears to be individualized even when vitamin D blood levels are similarly elevated.
In one case study, a boy developed stomach pain and constipation after taking improperly labeled vitamin D supplements, whereas his brother experienced elevated blood levels without any other symptoms (16).
In another case study, an 18-month-old child who was given 50,000 IU of vitamin D3 for 3 months experienced diarrhea, stomach pain, and other symptoms. These symptoms resolved after the child stopped taking the supplements (17).
Summary Stomach pain, constipation, or diarrhea may result from large vitamin D doses that lead to elevated calcium levels in the blood.
5. Bone loss
Because vitamin D plays an important role in calcium absorption and bone metabolism, getting enough is crucial for maintaining strong bones.
However, too much vitamin D can be detrimental to bone health.
Although many symptoms of excessive vitamin D are attributed to high blood calcium levels, some researchers suggest that megadoses may lead to low levels of vitamin K2 in the blood (18).
One of vitamin K2’s most important functions is to keep calcium in the bones and out of the blood. It’s believed that very high vitamin D levels may reduce vitamin K2 activity (18, 19).
To protect against bone loss, avoid taking excessive vitamin D supplements and take a vitamin K2 supplement. You can also eat foods rich in vitamin K2, such as grass-fed dairy and meat.
Summary Although vitamin D is required for calcium absorption, high levels may cause bone loss by interfering with vitamin K2 activity.
6. Kidney failure
Excessive vitamin D intake frequently results in kidney injury.
In one case study, a man was hospitalized for kidney failure, elevated blood calcium levels, and other symptoms that occurred after he received vitamin D injections prescribed by his doctor (20).
In one study in 62 people who received excessively high-dose vitamin D injections, each person experienced kidney failure — whether they had healthy kidneys or existing kidney disease (21).
Kidney failure is treated with oral or intravenous hydration and medication.
Summary Too much vitamin D may lead to kidney injury in people with healthy kidneys, as well as those with established kidney disease.
Vitamin D is extremely important for your overall health. Even if you follow a healthy diet, you may require supplements to achieve optimal blood levels.
However, it’s also possible to have too much of a good thing.
Make sure to avoid excessive doses of vitamin D. Generally, 4,000 IU or less per day is considered safe, as long as your blood values are being monitored.
In addition, make sure you purchase supplements from reputable manufacturers to reduce the risk of accidental overdose due to improper labeling.
If you’ve been taking vitamin D supplements and are experiencing any of the symptoms listed in this article, consult a healthcare professional as soon as possible.
lourideBy Kelly Bonyata, IBCLC
Vitamin and mineral supplements are not generally necessary for the average healthy, full-term breastfed baby during the first year. Studies have shown that most vitamins, fluoride, iron, water, juice, formula and solid foods are not beneficial to healthy breastfed babies during the first six months, and some can even be harmful. There are certain cases where a vitamin supplement may be needed for a breastfed baby during the first year (see below for specifics).
The American Academy of Pediatrics does recommend that all babies receive a vitamin K injection soon after birth to reduce the risk of hemorrhagic disease of the newborn, and routine vitamin D supplementation due to decreased sunlight exposure and an increase in rickets.
Some very premature babies (weighing less than 1500 grams/3.3 pounds) may need extra vitamins and minerals, which can be added to their mother’s milk before being given to the baby.
Following is more specific information on baby’s needs for certain vitamins and minerals.
Breastmilk is a natural, excellent source of vitamin A. Promoting breastfeeding is the best way to protect babies from Vitamin A deficiency. Vitamin A deficiency is rare in breastfed babies even in areas of the world where vitamin A deficiency is widespread.
Breastmilk: A Critical Source of Vitamin A for Infants and Young Children (PDF format) from the LINKAGES Project. Also available in English, French, Portuguese and Spanish.
Vitamin B1 (thiamine)
If mom is getting enough thiamine, then her milk has enough for baby and supplements are not needed. If mom is thiamine-deficient, then adding additional thiamine to mom’s diet should increase the amount of thiamine in her milk (since this vitamin is water-soluble) to the necessary levels. Thiamine deficiency (beriberi) is rare in the United States.
Vitamin B2 (riboflavin)
Supplements are not recommended for breastfed babies, as riboflavin deficiency is rare in developed countries. The levels of riboflavin in human milk are quite constant and are usually affected only by large maternal supplements (3x the maternal RDA).
If mom gets adequate amounts of vitamin B6, then additional supplements are not necessary for a healthy baby. If mom is not getting enough vitamin B6, then adding additional vitamin B6 to mom’s diet will increase the levels in her milk to the required levels.
See Does my baby need vitamin B12 supplements?
Breastfed babies should not be routinely supplemented with vitamin C except in cases of obvious scurvy (vitamin C deficiency). FDA requirements for breastfeeding mothers for this vitamin are 120 mg per day (over 18 years) and 115 mg per day (under 18 years). If you smoke, add 35 mg per day to these amounts. Supplements of vitamin C for a mother do not significantly alter the amounts in breastmilk, as they remain fairly constant no matter what mother’s intake levels (assuming the mother is not vitamin-C deficient). For a mother deficient in vitamin C, supplements will increase milk levels.
Breastfed babies do not need additional calcium over that which they get from breastmilk and (during the second 6 months) complementary foods. According to the American Academy of Pediatrics Policy Statement on Calcium Requirements of Infants, Children, and Adolescents:
No available evidence shows that exceeding the amount of calcium retained by the exclusively breastfed term infant during the first 6 months of life or the amount retained by the human milk-fed infant supplemented with solid foods during the second 6 months of life is beneficial to achieving long-term increases in bone mineralization.
The American Academy of Pediatrics recommends that all babies receive routine vitamin D supplementation (400 IU per day) due to decreased sunlight exposure and an increase in rickets.
The babies who do need these supplements need them due to a lack of sufficient sunlight. Factors that put your breastfed baby at risk for vitamin D deficiency (rickets) are:
- Baby has very little exposure to sunlight. For example: if you live in a far northern latitude, if you live in an urban area where tall buildings and pollution block sunlight, if baby is always completely covered and kept out of the sun, if baby is always inside during the day, or if you always apply high-SPF sunscreen.
- Both mother and baby have darker skin and thus require more sun exposure to generate an adequate amount of vitamin D. Again, this is a “not enough sunlight” issue – the darker your skin pigmentation, the greater the amount of sun exposure needed. There is not much information available on how much more sunlight is needed if you have medium or darker toned skin.
- Mother is deficient in vitamin D – there is increasing evidence in the last few years indicating that vitamin D deficiency is becoming more common in western countries. The amount of vitamin D in breastmilk depends upon mom’s vitamin D status. If baby gets enough sunlight, mom’s deficiency is unlikely to be a problem for baby. However, if baby is not producing enough vitamin D from sunlight exposure, then breastmilk will need to meet a larger percentage of baby’s vitamin D needs. If mom has minimal exposure to sunlight (see above examples) and is not consuming enough foods or supplements containing vitamin D, then she may be vitamin D deficient.
The best way to get vitamin D, the way that our bodies were designed to get the vast majority of our vitamin D, is from sun exposure. Depending upon where you live and how dark your skin is, going outside regularly may be all that is required for you or your baby to generate adequate amounts of vitamin D. However, one of the problems with getting your vitamin D with sun exposure is simply that it’s hard to determine how much time outside is needed since it depends on so many factors (skin tone, latitude, time of year, how much skin is exposed, amount of air pollution, etc.) Keep in mind that there is also a concern of sunburn and increased risk of skin cancer with too much sun exposure.
The primary source of vitamin D for babies, other than sunlight, is the stores that were laid down in baby’s body prior to birth. Because mom’s vitamin D status during pregnancy directly affects baby’s vitamin D stores at birth and particularly during the first 2-3 months, it is very helpful for pregnant women to make sure they are getting enough vitamin D.
Adding a vitamin D supplement to mom’s diet and/or exposure to ultraviolet light will increase the amount of vitamin D in her breastmilk. As long as mom is vitamin D sufficient, her breastmilk will have the “right” amount of vitamin D. However, babies were “designed” to get only part of their vitamin D from breastmilk and the remainder from sun exposure – what if baby does not get a minimum amount of sun? A 2015 study concluded that “Maternal vitamin D supplementation with 6400 IU/day safely supplies breast milk with adequate vitamin D to satisfy her nursing infant’s requirement and offers an alternate strategy to direct infant supplementation.” Read more about this study and vitamin D in our interview with Dr. Bruce Hollis. A 2004 study determined that supplementing the mother with 2000-4000 IU vitamin D per day safely increased mother’s and baby’s vitamin D status: the 2000 IU/d dose resulted in a limited improvement, and “A maternal intake of 4000 IU/d could achieve substantial progress toward improving both maternal and neonatal nutritional vitamin D status.” A Finnish study showed that supplementing the mother with 50 µg (2000 IU) vitamin D per day was as effective for maintaining baby’s vitamin D levels as supplementing the baby with 10 µg (400 IU) per day.
See also: Vitamin D and Breastfeeding: An interview with Bruce Hollis, PhD
Papadimitriou DT. The Big Vitamin D Mistake. J Prev Med Public Health. 2017
Wagner CL, Greer FR and the Section on Breastfeeding and Committee on Nutrition Prevention of Rickets and Vitamin D Deficiency in Infants, Children, and Adolescents. Pediatrics. November 2008; 122;1142. doi: 10.1542/peds.2008-1862
Hollis BW, Wagner CL, et al. Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics. 2015; 136;625. doi: 10.1542/peds.2015-1669
No known deficiencies of vitamin E have been described in healthy term infants fed human milk. Vitamin E supplements for mothers and their breastfed babies are not indicated.
Currently there is no evidence indicating that fluoride supplements in infancy improve a breastfed baby’s dental health. Dr. Ruth Lawrence (in Breastfeeding: A Guide for the Medical Profession, 7th ed., p.932) states:
The supplementation of fluoride in the diet of a healthy breastfed infant is no longer recommended by the AAP. Evidence supports the contention that there is adequate fluoride in human milk, and fluorosis from excessive amounts is a concern.
The American Academy of Pediatrics recommends that fluoride supplements only be given after 6 months, and only to children whose primary water source is deficient in fluoride.
The American Academy of Pediatric Dentistry is slightly more conservative, suggesting that the caries risk to the individual child also be considered: “The AAPD endorses the supplementation of a child’s diet with fluoride according to established guidelines1, when fluoride levels in community water supplies are sub- optimal and after consideration of sources of dietary fluoride and the caries risk of the child.”
Many city water systems add fluoride to the water. If you use well water or bottled water, it’s unlikely that fluoride has been added to your water, but it may still be there. Fluoride occurs naturally in most water, so you really need to know how much fluoride is in your water before you decide whether to supplement.
How do you find out how much fluoride is in your drinking water?
- If you use city water, call your local water department to find out.
- If you use bottled water, call the bottling company.
- If you use well water, you can ask your local water department about having your water tested for fluoride – fluoride analysis isn’t very expensive.
After you know how much fluoride is already in your drinking water and determine whether your child is at high risk for developing cavities, you can decide whether fluoride supplementation might be beneficial.
Fluoride Supplements from AskDrSears.com
Fluoride Dietary Supplementation from the American Academy of Pediatrics
Rozier RG, Adair S, Graham F, et al. Evidence-based clinical recommendations on the prescription of dietary fluoride supplements for caries prevention: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2010;141(12):1480-9.
Journal search on Fluoride and Human Milk
Over 70 Years of Community Water Fluoridation from the CDC
Folic acid (folate)
Folic acid deficiency has not been reported in breastfed, full-term infants, and supplements are not recommended.
Here’s my information page on Is Iron Supplementation Necessary?
Baby’s vitamin K stores at birth are very low. Vitamin K is needed for proper blood clotting, and a deficiency of this vitamin causes a syndrome called Vitamin K deficiency bleeding (VKDB). Increasing mom’s vitamin K intake increases the amount of vitamin K in her milk. The American Academy of Pediatrics recommends:
Intramuscular vitamin K1 (phytonadione) at a dose of 0.5 to 1.0 mg should routinely be administered to all infants on the first day to reduce the risk of hemorrhagic disease of the newborn. A delay of administration until after the first feeding at the breast but not later than 6 hours of age is recommended. A single oral dose of vitamin K should not be used, because the oral dose is variably absorbed and does not provide adequate concentrations or stores for the breastfed infant.
Evidence on: The Vitamin K Shot in Newborns by Nicole Churchin
Vitamin K1 Prophylaxis from the British Columbia Reproductive Care Program
Niacin deficiency in breastfed infants in developed countries is extremely rare, and no supplementation is recommended.
Healthy full-term breastfed babies do not need additional zinc past what they get from breastmilk and (after 6-8 months) from complementary foods. Good sources of zinc include meat (especially red meat) and yogurt. Signs of a mild zinc deficiency include: lessened appetite, lowered immune function, limited activity, growth faltering. Low birth weight, small for gestational age and premature infants are at risk for zinc deficiency.
If you’re worried that your baby will need vitamins because your diet is not ideal
Studies have shown that when a mother is deficient in a certain nutrient, improving the mother’s nutrition and/or supplementing her diet (multivitamins, etc.) may be as effective or more effective than giving her baby vitamin supplements.
More information @
- How does mom’s diet affect her milk?
- Vitamins for nursing moms
FAQ on Vitamin and Fluoride Supplements for the Breastfed Baby from La Leche League.
The Science of Feeding Your Children by Jay Gordon, MD
Vitamin & Iron Supplements from the American Academy of Pediatrics
Nutrient Information from the the American Society for Nutritional Sciences includes current information on food sources, diet recommendations, deficiencies, toxicity, clinical uses, recent research and references for further information for many micro- and macronutrients.
USDA Food Composition Data
Nutrition Analysis Tool (NAT) from the Food Science and Human Nutrition Department at the University of Illinois
American Academy of Pediatrics, Committee on Nutrition. Fluoride supplementation for children: interim policy recommendations. Pediatrics. 1995;95(5):777
American Academy of Pediatrics, Work Group on Breastfeeding. Breastfeeding and the Use of Human Milk. Pediatrics. 1997;100(6):1035
Baker SS, Cochran WJ, Flores CA, Georgieff MK, Jacobson MS, Jaksic T, Krebs NF. American Academy of Pediatrics. Committee on Nutrition. Calcium Requirements of Infants, Children, and Adolescents. Pediatrics 1999 Nov;104(5 Pt 1):1152-7.
Milner JD, Stein DM, McCarter R, Moon RY. Early Infant Multivitamin Supplementation Is Associated With Increased Risk for Food Allergy and Asthma. Pediatrics. 2004 Jul;114(1):27-32.
Greer, FR. Do breastfed infants need supplemental vitamins? Pediatr Clin North Am (United States), Apr 2001, 48(2) p 415-23
In conclusion, in healthy, breastfed infants of well-nourished mothers, there is little risk for vitamin deficiencies and the need for vitamin supplementation is rare. The exceptions to this are a need for vitamin K in the immediate newborn period and vitamin D in breastfed infants with dark skin or inadequate sunlight exposure.
Krebs NF, Westcott J. Zinc and breastfed infants: if and when is there a risk of deficiency? Adv Exp Med Biol. 2002; 503: 69-75.
Krebs NF. Dietary zinc and iron sources, physical growth and cognitive development of breastfed infants. J Nutr 2000 Feb;130(2S Suppl):358S-360S.
Mohrbacher, N. and Stock, J. BREASTFEEDING ANSWER BOOK. Schaumburg, Illinois, USA; LLLI 1997.
Butte NF, Lopez-Alarcon MG, Garza C. Nutrient adequacy of exclusive breastfeeding for the term infant during the first six months of life. Geneva, Switzerland; World Health Organization 2002, pp. 26-30.
Dietary Reference Intakes (DRI) and Recommended Dietary Allowances (RDA) from the US Department of Agriculture’s Food and Nutrition Information Center
FDA Issues Recommendations for Parents, Industry on Infant Vitamin D Supplements
In 2008, the American Academy of Pediatrics doubled the recommended daily intake of vitamin D(pediatrics.aappublications.org) for infants and children from 200 international units, or IU, a day to 400 IU.
But Linda Katz, M.D., M.P.H., interim chief medical officer in the agency’s Center for Food Safety and Applied Nutrition, said in a June 15 teleconference that some liquid vitamin D products come with droppers that can hold significantly more than the recommended amount of liquid vitamin D.
In a June 15 safety alert(www.fda.gov), the FDA recommended that 400 units be clearly and accurately marked on droppers packaged with vitamin D supplements. It also recommended that products intended specifically for infants have droppers that hold no more than 400 units.
Vitamin D promotes calcium absorption and plays a key role in the development of strong bones. However, Katz said excessive vitamin D can cause nausea, vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, fatigue, and kidney damage.
The agency said other potential serious consequences of overdose may include cardiac arrhythmias, osteomalacia and hypercalcemia, which can lead to soft-tissue deposition of calcium, resulting in other associated problems, such as hypertension.
The agency issued a number of recommendations aimed at parents and other caregivers.
Vitamin D, Your Baby, and You
It is a known fact that human milk is the superior infant food. Human milk is the most complete nutritionally, immunologically, and is the only food designed specifically for your baby. Given that it is expected to be “perfect,” you may be confused about why your baby’s doctor is encouraging you to give your breastfed baby vitamin D supplements.
In 2008, the American Academy of Pediatrics (AAP) amended its recommendation regarding vitamin D supplementation of infants and children. The current recommendation reads:
“A supplement of 400 IU/day of vitamin D should begin within the first few days of life and continue throughout childhood. Any breastfeeding infant, regardless of whether he or she is being supplemented with formula, should be supplemented with 400 IU of vitamin D.” (Pediatrics 2008; 122(5):1142-52)
Why is vitamin D important?
Vitamin D is a key nutrient in the maintenance of bone health in children and adults. Because vitamin D is essential for promoting calcium absorption in the body, vitamin D deficiency is marked by such conditions as rickets (in children), osteomalacia (in adults), and can lead to osteoporosis if left unchecked longterm. While researchers are still working to prove a cause-and-effect relationship between low levels of vitamin D and other health issues, anecdotal and epidemiological (tracking the occurrence of a disease or condition in a population over time) correlations have been found between vitamin D insufficiency/deficiency and the following:
- Cancers; specifically of the colon, breast, and prostate
- Hypertension (due to calcium’s role in the regulation of blood pressure)
- Diabetes (both type I and type II); insulin resistance/pre-diabetes may also be related to vitamin D insufficiency
- Multiple sclerosis, rheumatoid arthritis, and other autoimmune conditions
I spend a lot of time outside. Surely I’m not deficient in vitamin D.
There are a few factors that have an impact on the vitamin D content of a mother’s milk. Most significantly, the vitamin D status of the mother during pregnancy and lactation impacts the vitamin D status of the baby at birth, as well as mother’s ability to transfer vitamin D via her milk. In 2003, data released by the Thrasher Research Fund/US National Institutes of Health reported that 81% of women of childbearing age have insufficient levels of vitamin D. While there is still some uncertainty about the optimal level of vitamin D for adults, there is recent agreement among the medical community that vitamin D insufficiency is represented by a blood level of less than 32 ng/mL. Those with blood levels below 20 ng/mL are considered deficient in vitamin D. How has vitamin D insufficiency reached epidemic proportions?
We as a population have heeded the warnings of the medical community and limited our unprotected exposure to the sun. The use of sunscreen, while important in the protection against skin cancer, blocks the rays of the sun that are necessary for our bodies to convert sunlight into vitamin D through the skin.
Additionally, many of us live north of the 35th parallel, where, for most months of the year, the sun’s rays are not strong enough to assist our bodies in making enough vitamin D. This is the case even with prolonged, unprotected sun exposure. Those living where clouds often cover the sky or in cities with poor, polluted air quality also will be deprived of optimum sun exposure for the manufacture of vitamin D.
People with darker skin colors will be more likely to have low levels of vitamin D. This is due to the increased pigment in their skin which requires nearly four times the length of sun exposure in order to manufacture vitamin D.
Our bodies are designed to make very large amounts of vitamin D through exposure to the sun (10,000—20,000 IU in 24 hours, after 15—20 minutes of summer-sun exposure in a bathing suit/45—60 minutes of exposure for those with darker skin tones). However, in adults and children, the desire to avoid overexposure and sunburn has eclipsed our ability to absorb adequate amounts of sunlight to keep our vitamin D status at a normal level.
I eat a healthy diet and take vitamins. My vitamin D status is probably fine.
Until very recently, it was unknown that low vitamin D levels in the body could be related to conditions other than overt bone problems, such as rickets in children and osteomalacia in adults. Consequently, vitamin D insufficiency and deficiency goes unnoticed and underdiagnosed. It was also commonly believed that adverse effects could result from too much vitamin D. Current adult Recommended Daily Intakes (RDI) for vitamin D in most of the world are still quite low, and are now believed by many researchers to be inadequate for achieving or sustaining normal vitamin D levels. Most multivitamins only contain 200—400 IU of vitamin D. While this amount does not appear to be sufficient for adults, 400 IU/day is sufficient for babies, beginning in the first few days of life, as recommended by the American Academy of Pediatrics.
There are few dietary sources of vitamin D, but they are not significant enough to provide the amount of vitamin D that most adults really need. These dietary sources include:
- Cod liver oil
- Fish, such as mackerel, tuna, and salmon
- Egg yolk
- Beef liver
- Fortified dairy products
Recent research emphasizes the need for more than the currently recommended intake of 600 IU/day of vitamin D for adults.
Should I supplement my breastfed baby with vitamin D?
Your baby’s doctor probably recommends that you supplement your baby with 400 IU/day of vitamin D, as per the AAP 2008 recommendation. The recommendation is based on the following well-established facts:
- Vitamin D deficiency can occur very early in life, particularly because many pregnant women have deficient blood levels of vitamin D.
- Vitamin D levels (measured by a blood test for 25-OH-D) of unsupplemented breastfed infants are often below 20 ng/mL, particularly in the winter and latitudes farther from the equator, probably as a result of maternal deficiency.
- Adequate sunlight exposure for sufficient manufacture of vitamin D in an infant is difficult to assess and often not achieved.
- Optimal vitamin D levels in breastfed infants can be maintained with supplementation of 400 IU/day of vitamin D. Most commonly, multivitamins are prescribed for infants. If you choose to supplement your baby and are uncomfortable with supplementation of vitamins other than D (since your milk alone provides optimal amounts of those other nutrients), ask your doctor to recommend a vitamin D-only preparation for your baby. They are available but may be more expensive than the multivitamin. Additionally, doctors may be more comfortable prescribing multivitamin preparations because those have been available for many years, while the vitamin D-only preparation is relatively new.
Even though it is likely, given the above factors, that your baby needs vitamin D supplements, you may opt to have your baby’s vitamin D level assessed with a blood test measuring 25-hydroxy vitamin D (25 OH-D). Your baby’s doctor can help you determine whether vitamin D supplements are, indeed, warranted.
Should I take Vitamin D Supplements?
Research shows that high dose maternal vitamin D supplementation (4000-6400 IU/d or a single monthly dosage of 150,000 IU) can enrich breastmilk adequately for infants. Maternal supplementation may better ensure adequate intake for both mother and baby as studies also show a higher preference for this method. While the currently recommended safe upper limit for vitamin D intake is 4000 IU/day, it is very important to check with your doctor and have your own vitamin D status assessed by a blood test before you begin supplementing at levels higher than the current RDI of 600 IU/ day. Debates continue over what an optimal level of vitamin D is for an adult, and recent research has indicated that pregnant and lactating women might need more vitamin D than adults who are not bearing children.
It is important to note that a mother’s milk may not lack vitamin D because she, herself, does not have enough in her body. Supplementing the baby takes care of his needs, but does not address the deficiency in the mother, which may lead to long-term, chronic compromises in her health. Researchers are still determining what “optimal” levels of 25-OH-D should be, but the following can serve as a guideline for total 25-OH-D:
- <20 ng/mL: Vitamin D deficiency
- 20–31 ng/mL: Vitamin D insufficiency
- 32 ng/mL: Sufficient vitamin D levels
The Academy of Breastfeeding Medicine (a global organisation) recommends that “The breastfeeding infant should receive vitamin D supplementation for a year, beginning shortly after birth in doses of 10–20 lg/day (400–800 IU/day) (LOE IB). This supplement should be cholecalciferol, vitamin D3, because of superior absorption unless a vegetable source such as ergocaliferol vitamin D2, is desired. … Vitamin D also may be delivered adequately through human milk.”
As a nursing mother, if your own levels of Vitamin D are low, you may want to consider taking a vitamin D supplement to support your own needs and to increase levels in your milk. A rigorous study reported that “Maternal vitamin D supplementation with 6400 IU/day safely supplies breast milk with adequate vitamin D to satisfy her nursing infant’s requirement and offers an alternate strategy to direct infant supplementation.”
Oberhelman SS, Meekins ME, Fischer PR, et al. Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial. Mayo Clin Proc. 2013; 88(12): 1378-1387.
Babies need vitamin D for healthy growth and development. It helps them build strong, healthy bones and teeth.
Babies who don’t get enough vitamin D are said to have a deficiency. If the levels are low enough, they are at risk of getting rickets, a disease that affects the way bones grow and develop.
You can make sure your baby has enough vitamin D by giving a daily supplement (a dose of drops every day). This should start as soon as your baby is born.
How do we get vitamin D?
Vitamin D comes from different sources:
- Sunlight: Vitamin D is formed naturally when skin is exposed to sunlight. Because Canada is located so far north, sunlight isn’t enough at certain times of the year and in certain places. Also, sunscreen and clothing, which protect babies from the harmful effects of the sun, won’t allow vitamin D to be formed.
- Foods: In Canada, vitamin D is added to cow’s milk and margarine during production. Some foods—like salmon, tuna, and liver—are good sources of vitamin D.
- Vitamin supplement: For babies, it comes in liquid form and is given daily with a dropper. It’s important to give your baby a supplement that is meant for babies. Read the instructions carefully to be sure you give your baby the right amount. If you are unsure, talk to your pharmacist.
How do I know if my baby is at risk of vitamin D deficiency?
Babies are most at risk of vitamin D deficiency if:
- They are breastfed.
- Their mothers don’t have enough vitamin D.
- They have darker skin.
- They live in northern communities.
All breastfed babies should get a daily supplement of vitamin D.
How much vitamin D should my baby receive?
- Babies who are breastfed should get 400 IU (international units) per day.
- Babies in northern communities (north of 55° latitude, which is about the level of Edmonton) or who have other risk factors (such as dark skin) should get 800 IU per day between October and April, when there is less sunlight.
If you aren’t sure about the right amount to give your baby, talk to your health care provider.
Why do breastfed babies need a vitamin D supplement?
Breast milk is the best food you can offer your growing baby. Even when your baby starts eating other foods, you can continue to breastfeed until 2 years of age and beyond.
But breast milk has only small amounts of vitamin D (4 to 40 IU per litre), which may not be enough to meet your baby’s needs. That’s why babies who are breastfed should receive a daily supplement of vitamin D from birth until they get enough from their diet.
If I am breastfeeding and I eat foods rich in vitamin D, do I still need to give my baby a supplement?
Yes. Although some foods are good sources of vitamin D, they won’t provide enough vitamin D to enrich your breast milk to the level your baby needs.
If you are breastfeeding, talk to your doctor about whether a supplement of 2000 IU/day is right for you.
Do babies who are formula-fed need extra vitamin D?
Since vitamin D is already added to infant formula, most full-term babies who are formula-fed don’t need a supplement. However, formula-fed babies in northern communities should receive a supplement of 400 IU/day from October to April to ensure they have enough vitamin D.
Should pregnant women take vitamin D supplements?
How much vitamin D you get while you’re pregnant will affect how much vitamin D your baby has at birth. A baby born to a mother who is vitamin D deficient is more likely to have a vitamin D deficiency.
You are more likely to be vitamin D deficient if:
- you don’t use products like milk and margarine, which in Canada are fortified with vitamin D.
- you do not have much exposure to the sun, or if your skin is covered much of the time.
- you do not take vitamin D supplements.
If you are pregnant, talk to your doctor about whether a supplement of 2000 IU/day is right for you.
More information from the CPS:
- Feeding your baby in the first year
- Vitamin D supplementation: Recommendations for Canadian mothers and infants (position statement)
Reviewed by the following CPS committees:
- First Nations, Inuit and Métis Health Committee
- Nutrition and Gastroenterology Committee
Last Updated: January 2016