Vitamin
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: Compatible
PREGNANCY SUMMARY
The near absence of human pregnancy experience prevents a complete assessment of the risk for the embryo and fetus. However, there is no evidence that recommended doses of vitamin D during pregnancy are harmful.
FETAL RISK SUMMARY
Calcitriol is one of three physiologically active forms of vitamin D (see Vitamin D). Calcitriol is teratogenic in rabbits given daily doses that were about two and six times the maximum recommended human dose based on BSA (MRHD) (1). Defects observed included external and skeletal malformations. The high dose given on gestation days 7–18 also increased maternal mortality, decreased mean fetal body weight, and reduced the number of newborn surviving to 24 hours. No teratogenic effects were observed in rats treated with daily doses up to about five times the MRHD (1). However, hypercalcemia was measured in the offspring of rats given doses that were about one and three times the MRHD (1).
The manufacturer cites a case of mild hypercalcemia during the first 2 days of life in an infant who was exposed to a maternal dose of 17–36 mcg/day (approximately 17–36 times the maximum recommended dose) during pregnancy (1). The hypercalcemia resolved by the third day.
BREASTFEEDING SUMMARY
See VITAMIN D
Reference
1.Product information. Rocaltrol. Roche Laboratories, 2000.