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Drugs and Lactation Database (LactMed) [Internet].

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Vitamin D

Last Revision: April 20, 2020.

Estimated reading time: 15 minutes

CASRN: 67-97-0 50-14-6

image 134971039 in the ncbi pubchem databaseimage 134971005 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

Vitamin D is a normal component of human milk. Daily maternal vitamin D supplementation in the 400 to 2,000 IU (10 to 50 mcg) range produces milk concentrations that are inadequate to deliver the daily requirement to an exclusively breastfed infant, and inadequate to correct pre-existing infant vitamin D deficiency through breastfeeding alone. Breastfeeding mothers who take vitamin D supplements in this range should give their infants a daily vitamin D supplement of at least 400 IU (10 mcg) to meet pediatric nutritional guidelines.[1-5] Daily maternal vitamin D dosages at or above 4,000 IU (100 mcg) achieve milk levels can potentially meet the daily infant goal intake of at least 400 IU (10 mcg), depending on the mother's underlying vitamin D status and daily infant milk intake. Obese mothers may have higher requirements.

Holder pasteurization decreased median levels of the major forms of vitamin D in breastmilk by 20% in one study.[6]

Drug Levels

Vitamin D in collected whole milk partitions extensively into the fat fraction after 1 to 2 days when stored under refrigeration.[7] The major forms of vitamin D present in breastmilk are cholecalciferol (vitamin D3), ergocalciferol (vitamin D2), and their respective 25-hydroxylates (25-OH) also known as calcidiols. Dihydroxylated metabolites are also present in milk, but in such low quantities that their contribution to total milk vitamin D activity is not routinely accounted for.[7-10] Human vitamin D deficiency is defined as a 25-OH vitamin D serum level <20 mcg/L (<50 nmol/L), and vitamin D insufficiency as 20 to 30 mcg/L (50 to 75 nmol/L). The goal of vitamin D supplementation is to achieve a serum concentration of 30 to 100 mcg/L (75 to 250 nmol/L).[11] Darker skin pigmentation is a risk factor for vitamin D deficiency due to decreased UVB-mediated cutaneous vitamin D3 synthesis.[12] U.S. infants and children with darker skin pigments do not achieve optimal synthesis, even during summer months, from everyday outdoor sun exposures.[13]

Breastmilk levels of vitamin D and 25-OH vitamin D are 10 to 20% and 1 to 2% of maternal blood levels, respectively.[8,14-16] Levels are 1.5 to 2 times higher in hindmilk than in foremilk.[15] Maternal serum and milk levels and breastfed infant serum levels can be higher during summer and at lower latitudes due to increased sunlight availability and skin ultraviolet B light (UVB) exposure.[16-21] As a mother's vitamin D blood levels increase due to increasing light exposure or dietary intake, milk vitamin D content also increases.[15,21-24] The United States Food and Drug Administration requires supplement manufacturers to label products in mcg rather than IU: 1 mcg = 40 IU.

Maternal Levels. Lactating women with nondeficient vitamin D status (serum 25-OH vitamin D >20 mcg/L or >50 nmol/L) taking 400 to 2000 IU daily have an average or median reported total vitamin D antirachitic activity in their milk of 50 to 80 IU/L.[2,8,15,23,25-30] Based on these reported milk levels, an exclusively breastfed infant will ingest 8 to 12 IU/kg daily of vitamin D. In breastfeeding mothers with non-deficient vitamin D status taking 4,000 IU daily of vitamin D, average milk levels are approximately 130 IU/L after 3 months of supplementation. Based on this reported average milk level, an exclusively breastfed infant would receive 20 IU/kg daily of vitamin D.[29]

Nineteen fully breastfeeding women were given either 400 or 6,400 IU daily of vitamin D3 beginning at 1 month postpartum. Dietary intake and skin pigment changes did not differ between the two groups. Average maternal baseline vitamin D serum levels were >30 mcg/L. Over 7 consecutive monthly measurements, average milk vitamin D levels increased from 59.6 IU/L at baseline to 76.3 IU/L at 7 months in the 400 IU daily group, and steadily increased in the 6,400 IU daily group from 82.4 IU/L at baseline, to 374.4 IU/L after 4 months, 555.2 IU/L after 5 months, 624.5 IU/L after 6 months, and 873.5 IU/L after 7 months. Milk level changes paralleled maternal vitamin D status changes. Maternal serum 25-OH-vitamin D levels in the 6,400 IU group increased from 34 to 58.8 mcg/L over the 7-month study period. The authors suggested that the increase in both milk and serum levels towards the end of the 7-month study period in both groups was due to increased outdoor activity and sun exposure coinciding with warmer months.[25] Based on the average milk concentration of 374.4 IU/L after 4 months of treatment in the 6,400 IU daily group, an exclusively breastfed infant would ingest about 60 IU/kg daily. This would meet the 400 IU daily requirement for the average sized 5-month-old infant.

Forty exclusively breastfeeding mothers in the Northern U.S. were given oral vitamin D3 150,000 IU one time or 5000 IU daily for 28 days. Their infants were between 4 and 28 weeks old at study enrollment. Average milk vitamin D3 levels in the single dose group increased from below the limit of quantification (<280 IU/L) at baseline to approximately 1600 IU/L after 1 day, decreasing to 440 IU/L by 7 days after the dose, to undetectable again by day 14. Average milk D3 levels in the once daily group increased from undetectable at baseline to 320 IU/L by day 3 and remained at about 320 IU/L for the remaining 28-day study period; 25-OH D was not detected in milk in either group.[16] Based on the reported average level, an exclusively breastfed infant would receive approximately 50 IU/kg daily from a maternal daily dosage of 5,000 IU D3.

In a mother taking long-term vitamin D2 100,000 IU daily during pregnancy and lactation to maintain normal calcium and phosphorus status after a pre-pregnancy thyroid-parathyroidectomy, plus a daily prenatal vitamin containing 400 IU vitamin D, breastmilk antirachitic activity at 14 days postpartum was 6,700 IU/L. Milk vitamin D2 concentration was 126 mcg/L and 25-OH vitamin D2 was 8.3 mcg/L.[31] These values are approximately 800-times and 80-times higher, respectively, than those normally seen in lactating women taking a 400 IU daily of vitamin D2 supplement.[26] Vitamin D3 forms in milk were undetectable. The mother's serum vitamin D2 and 25-OH-D2 levels were elevated at 500-times normal levels.

Eighty-five breastfeeding mothers in Finland were given an oral vitamin D2 or D3 supplement of 1000 IU daily, 2000 IU daily or no supplementation. Milk was collected at 8, 15, and 20 weeks postpartum. Milk levels were highest in September, and higher in September and May than December and February. Supplementation significantly increased milk antirachitic activity in winter months compared to no supplementation, but not in summer. Median hindmilk antirachitic activity in February was 51 IU/L in the 1,000 IU daily group and 92 IU/L in the 2,000 IU daily group. The range was 20 to 190 IU/L in both groups. For the non-supplemented mothers in February, the median milk level was 35 IU/L ranging from 15 to 100 IU/L. Median hindmilk antirachitic activity in September was 136 IU/L in the 1,000 IU group, and 114 IU/L in the unsupplemented group, with a range of approximately 50 to 320 IU/L in both groups.[14] Diet, daily sunlight exposure, and maternal vitamin D status were not controlled for, and likely explain the highly variable milk levels reported. The positive supplement effect on vitamin D levels in winter but not in summer seen in this study has been also reported in pregnant mothers and their serum 25-OH-vitamin D levels.[32]

In a Danish study of 48 breastfeeding women with normal vitamin D status, 70 to 80% of whom were taking a 400 IU daily supplement, vitamin D and 25 to OH-D milk levels were highest in July, approximately 3 nmol/L and 1.5 nmol/L, respectively, and lowest in February (<1 nmol/L for both). More milk samples collected in winter months were below the vitamin D detection limit of 0.14 nmol/L than in summer (49% vs 24%). The median total vitamin D antirachitic activity in milk was 130 IU/L in the summer months and 80 IU/L in winter. Breastmilk concentrations correlated with maternal median serum 25-OH vitamin D concentrations, which were at their highest in July (90 nmol/L) and lowest in February (50 nmol/L).[15]

Five white-skinned, lactating mothers were exposed to artificial UVB light at approximately the same exposure as 30 minutes of clear, midday, midlatitude, summer sun. Their average breastmilk vitamin D3 levels increased from 0.15 mcg/L (6 IU/L) prior to exposure to a peak of 0.85 to 3.7 mcg/L (34 to 148 IU/L) 2 to 3 days after exposure. Vitamin D3 milk levels were still slightly above baseline, 0.24 to 0.4 grams/L, at 14 days after exposure. Milk 25-OH-vitamin D3 and vitamin D2 did not significantly increase.[22]

Four hundred and sixty-seven women in Toronto, Canada had their vitamin D status evaluated during pregnancy at 28 to 31 weeks gestation, and again at 3 and 12 months postpartum. Two-thirds of the women studied had serum 25-OH-vitamin D <75 nmol/L throughout the study, and less than half were taking a standard vitamin D supplement. Their outdoor activity levels were considered low to moderate. Seasonal variation accounted for only a 5.4 nmol/L increase in serum 25-OH-vitamin D for those pregnant during winter and postpartum during spring and summer.[33] Although breastmilk vitamin D levels were not measured, this study suggests that seasonal changes in maternal blood and milk vitamin D levels are minimal in women living at high latitudes with low serum vitamin D levels, average outdoor exposure, and casual vitamin D supplementation.

A study comparing ten black and fifteen white exclusively breastfeeding mothers in a northern U.S. city reported average milk levels of 34 IU/L and 64 IU/L, respectively. Vitamin D3, D2, and 25-OH-vitamin D3 levels were all significantly lower in the milk of the black mothers, but 25-OH-vitamin D2 was similar between the two groups. The vitamin D3 milk level was significantly lower in the black mothers even when controlling for their less self-reported outdoor exposure. Maternal average daily vitamin D intake was similar between the two groups, but daily intake of vitamin D2 contained in prenatal vitamins was higher in the white mothers, which resulted in a higher proportion of their total vitamin D intake coming from D2. The average maternal serum 25-OH-vitamin D level was 27 mcg/L in black mothers and 45 mcg/L in white mothers, which was not significantly different.[23] This study suggests that skin pigmentation-related D3 synthesis efficiency differences can result in lower milk vitamin D3 and 25-OH-vitamin D3 levels in darker skinned mothers despite similar vitamin D intake and similar baseline vitamin D status.

Twenty-eight exclusively breastfeeding black mother-infant pairs participating in a study of postpartum vitamin D supplementation had significantly lower serum 25-OH-vitamin D levels compared to white study participants at the 4 to 6 weeks postpartum study entry; maternal levels were 69.8 nmol/L in blacks 105.4 nmol/L in whites; and infant levels were 24.1 nmol/L vs. 43.4 nmol/L, respectively. After four and seven months of vitamin D 6,400 IU daily maternal supplementation, maternal serum levels increased in the black mothers but they still had values 30 to 40 nmol/L less than white mothers. Infant values after seven months were not stratified by race.[34]

Infant Levels. When a mother has underlying vitamin D deficiency, her breastfed infant will have deficient serum levels (<20 mcg/L) when the mother is taking 400 to 1000 IU daily,[20,35,36] insufficient serum levels (20 to 30 mcg/L) when the mother is taking 2000 IU daily,[30,37] and sufficient serum levels (>30 mcg/L) when the mother takes 4,000 IU daily.[38] When a breastfed infant is given a daily 400 IU supplement, infant serum levels, on average, are sufficient (>30 mcg/L) without being excessive (>100 mcg/L) when the mother is also taking a daily 400 to 2,000 IU supplement.[39,40] Pregnant women living in higher latitudes with underlying normal vitamin D status who take a 2,000 IU daily vitamin D supplement beginning in the second trimester of pregnancy will usually have infants born with sufficient vitamin D status, which can be maintained for at least 8 weeks postpartum through exclusive breastfeeding without infant supplementation.[41]

Forty exclusively breastfeeding mothers in the Northern U.S. were given vitamin D3 150,000 IU one time or 5000 IU daily for 28 days. Their infants were between 4 and 28 weeks old and 68% were vitamin D deficient at study enrollment. In the single dose group, average infant serum 25-OH D levels increased from 16.3 mcg/L at baseline to 38.7 mcg/L at day 28.[16] A nearly identical increase was observed in the once daily group; from 16.9 mcg/L to 39.2 mcg/L.

Eighteen fully breastfeeding women in the southeast U.S. with nondeficient vitamin D status were given either 2,000 or 4,000 IU daily vitamin D beginning at 1 month postpartum. Mothers were instructed to minimize sun exposure. After 3 months of supplementation, average serum 25-OH-vitamin D levels increased from 7.9 to 27.8 mcg/L in the 2,000 IU daily group and from 13.4 to 30.8 mcg/L in infants of mothers in the 4000 IU daily group.[29] This study demonstrates that, on average, a 4,000 IU daily vitamin D supplement in lactating women who have non-deficient underlying vitamin D status can achieve marginally normal status in their breastfeeding infant without giving additional vitamin D directly to the infant. Such a strategy would not necessarily be effective in every mother-infant pair, and therefore infant serum 25-OH-vitamin D monitoring is recommended to confirm efficacy when using this strategy.

One hundred forty-eight fully breastfeeding women were given either 400 or 6,400 IU daily of vitamin D3 beginning within 4 to 6 weeks of delivery. Average baseline maternal serum 25-OH-vitamin D levels were >50 nmol/L, and average infant levels were <50 nmol/L (range undetectable to 113.8 nmol/L). Infants of mothers in the 400 IU daily group were given a 400 IU daily vitamin D supplement while those in the 6,400 IU daily group were given placebo. After 4 and 7 months, infants in both groups had serum 25-OH-vitamin D levels >75 nmol/L, achieving normal vitamin D status. The average levels at 4 months were 109 and 106.9 nmol/L in the 400 IU daily and 6,400 IU daily groups, respectively. At 7 months, average levels were 109.1 and 108.5 nmol/L, respectively, and the percentages of infants with levels <50 nmol/L were 4.3% and 4.2%, respectively.[34]

In a Turkish study of 90 exclusively breastfed infants, the effects of maternal vitamin D3 400 IU daily supplementation beginning during pregnancy and continuing postpartum was compared to no postpartum maternal vitamin D supplementation. Sun exposure of 3 or more days per week of at least 15 minutes daily was associated with a 5 mcg/L increase in serum 25-OH-vitamin D. Routinely wearing concealing clothing was associated with a 5 mcg/L decrease. Milk levels were not measured.[42]

In 38 exclusively breastfeeding women participating in a 6-month long prospective study to determine risks of vitamin D deficiency and rickets in breastfed infants, investigators reported a significant positive correlation between weekly maternal and infant UVB exposure and infant 25-OH-vitamin D3 levels among all participants. In a subset of 13 infants born in winter and not given any vitamin D, average levels increased from 10.5 mcg/L to 23.1 ng/L, and total 25-OH-vitamin D from 13 mcg/L to 25.1 mcg/L between 6 weeks and 6 months of age, coinciding with increased UVB exposure over that time.[36]

Maternal and infant serum 25-OH-vitamin D levels were 20 to 25 nmol/L lower on average when mothers were obese (BMI 30 kg/sq. m or greater) compared to mothers who were not overweight (BMI less than 25 kg/sq. m). An association between maternal weight and lower levels was significant even after adjusting for maternal race, education and insurance status. This study suggests that obese mothers may require higher vitamin D supplementation dosages.[43]

In a study of 115 exclusively breastfed infants in India born with severe vitamin D deficiency (cord serum 25-OH-vitamin D <11 mcg/L), whose mothers were given 60,000 units oral vitamin D3 or placebo once daily for 10 days beginning on the day of delivery, average infant serum 25-OH-vitamin D levels at 6 months of age were twice as high (30 vs 15 mcg/L) in the supplemented group compared to the placebo group. The frequency of severe deficiency at 6 months of age was lower in the supplemented group compared to the placebo group (8% vs 44%).[44]

One-hundred and fourteen healthy mothers in India were randomized to receive vitamin D3 60,000 units (1,500 mcg) or placebo as a single dose starting between 24 and 48 hours after delivery, and then repeated at 6, 10, and 14 weeks postpartum. Over 90% of participants were exclusively breastfeeding. At baseline, around 90% of all mothers and infants had vitamin D deficiency. At 6 months of age, average infant serum 25-OH D level was 19 mcg/L in the treatment group and 6 mcg/L in the placebo group, while vitamin D deficiency was present in 5% and 91% of infants, respectively. None of the infants were directly supplemented during the 6-month study period and sun exposure was similar between the two groups.[45]

Effects in Breastfed Infants

Maternal daily doses of 400 to 6,400 IU have not been associated with any short-term biochemical abnormalities in breastfed infants.[16,20,34-37,39,46]

An 11-day-old, exclusively breastfed, term, female neonate experienced asymptomatic, mild hypercalcemia (total serum calcium 11.4 mg/dL). The mother was taking maintenance vitamin D2 100,000 IU daily to maintain normal calcium and phosphorus status after a pre-pregnancy thyroid-parathyroidectomy, plus a prenatal vitamin containing 400 IU daily vitamin D (form not specified) during pregnancy and lactation. Vitamin D2 and 25-OH-vitamin D2 levels in cord blood and in milk at 14 days of age were both markedly elevated. Serum vitamin D levels were not measured in the infant.[31] The combination of high daily breastmilk vitamin D2 intake plus a high infant serum level present at birth likely contributed to the abnormal calcium value.

In a study in India, short-term maternal use of oral 60,000 IU vitamin D3 once daily for 10 days beginning after birth was not associated with any differences in serum calcium or phosphorus levels, or of urinary calcium/creatinine ratios, in their exclusively breastfed infants at 14 weeks and 6 months of age compared to infants of mothers given placebo. Infants of mothers given vitamin D had a lower frequency of biochemical rickets compared to placebo (0 vs 17%), but no difference in the frequency of radiological rickets (3.6% vs 3.4%).[44]

In a pilot study measuring the epigenomic effects of maternal vitamin D supplementation on the mother and infant, ten women were given 3,800 IU or 400 IU of oral vitamin D3 once daily beginning at 24 to 28 weeks gestation and continuing through 4-6 weeks postpartum. Gestational age at birth was not reported but presumed to be term. All infants were fully or partially breastfed. Those partially breastfed only received an average of about 10 mL formula daily during the study period. Methylation of cytosine-guanine dinucleotides in infant leukocyte genomic DNA were significantly different between the two groups.[47] Since two out of three infants in the low-dose group received postpartum vitamin D supplementation and five out of seven in the high-dose group did not, larger controlled studies are needed to determine the effects of vitamin D exposure through breastmilk on the infant epigenome.

One-hundred and fourteen healthy mothers in India were randomized to receive vitamin D3 60,000 units (1,500 mcg) or placebo as a single dose starting between 24 and 48 hours after delivery, and then repeated at 6, 10, and 14 weeks postpartum. Over 90% of participants were exclusively breastfeeding. At 6 months of age, 6 infants in the control group and no infants in the treatment group developed biochemical rickets, while 2 infants and 1 infant, respectively, developed radiological rickets. Infants of mothers in the treatment group reportedly had normal serum calcium and phosphorus concentrations at 6 months of age, although specific results were not given, and this outcome was not reported for the control group.[45]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Calcitriol

References

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Substance Identification

Substance Name

Vitamin D

CAS Registry Number

67-97-0 50-14-6

Drug Class

Breast Feeding

Lactation

Vitamins

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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