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Open Access Research

Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU) in pregnant and non-pregnant women

Daniel E Roth13*, Abdullah Al Mahmud2, Rubhana Raqib2, Robert E Black1 and Abdullah H Baqui12

Author Affiliations

1 Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA

2 International Center for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh

3 Current address: Department of Paediatrics, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada

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Nutrition Journal 2012, 11:114  doi:10.1186/1475-2891-11-114

Published: 27 December 2012

Abstract

Background

Improvements in antenatal vitamin D status may have maternal-infant health benefits. To inform the design of prenatal vitamin D3 trials, we conducted a pharmacokinetic study of single-dose vitamin D3 supplementation in women of reproductive age.

Methods

A single oral vitamin D3 dose (70,000 IU) was administered to 34 non-pregnant and 27 pregnant women (27 to 30 weeks gestation) enrolled in Dhaka, Bangladesh (23°N). The primary pharmacokinetic outcome measure was the change in serum 25-hydroxyvitamin D concentration over time, estimated using model-independent pharmacokinetic parameters.

Results

Baseline mean serum 25-hydroxyvitamin D concentration was 54 nmol/L (95% CI 47, 62) in non-pregnant participants and 39 nmol/L (95% CI 34, 45) in pregnant women. Mean peak rise in serum 25-hydroxyvitamin D concentration above baseline was similar in non-pregnant and pregnant women (28 nmol/L and 32 nmol/L, respectively). However, the rate of rise was slightly slower in pregnant women (i.e., lower 25-hydroxyvitamin D on day 2 and higher 25-hydroxyvitamin D on day 21 versus non-pregnant participants). Overall, average 25-hydroxyvitamin D concentration was 19 nmol/L above baseline during the first month. Supplementation did not induce hypercalcemia, and there were no supplement-related adverse events.

Conclusions

The response to a single 70,000 IU dose of vitamin D3 was similar in pregnant and non-pregnant women in Dhaka and consistent with previous studies in non-pregnant adults. These preliminary data support the further investigation of antenatal vitamin D3 regimens involving doses of ≤70,000 IU in regions where maternal-infant vitamin D deficiency is common.

Trial registration

ClinicalTrials.gov (NCT00938600)

Keywords:
Vitamin D; Bangladesh; Pregnancy; Pharmacokinetics