Abstract
BackgroundImprovements 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.MethodsA 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.ResultsBaseline 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.ConclusionsThe 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 registrationClinicalTrials.gov (NCT00938600)
Highlights
Improvements in antenatal vitamin D status may have maternal-infant health benefits
The pharmacokinetics of oral vitamin D3 are conventionally described with respect to its effect on the serum concentration of the predominant circulating metabolite, 25-hydroxyvitamin D ([25(OH)D]), which is a wellestablished biomarker of systemic vitamin D status [9]
An additional 16 non-pregnant and 14 pregnant participants enrolled in weekly-dose groups contributed at least one [25(OH)D] value on or prior to day 7
Summary
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. There is considerable speculation regarding the potential effects of vitamin D on both skeletal and extra-skeletal aspects of reproductive physiology and fetal development, yet it remains unknown whether there are benefits to improving maternal antenatal vitamin D status beyond the correction. The present study was conducted to assess changes in serum [25(OH)D] and calcium following a single oral vitamin D3 dose (70,000 IU) in non-pregnant women and pregnant women in the third trimester of pregnancy in Dhaka, Bangladesh. The aim was to generate preliminary pharmacokinetic (PK) and safety data to inform the design of supplementation regimens for use in future larger-scale trials of antenatal vitamin D supplementation in Bangladesh
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