Reasearch Awards nomination

Email updates

Keep up to date with the latest news and content from Nutrition Journal and BioMed Central.

Open Access Research

Randomized placebo-controlled trial of high-dose prenatal third-trimester vitamin D3 supplementation in Bangladesh: the AViDD trial

Daniel E Roth1*, Abdullah Al Mahmud2, Rubhana Raqib2, Evana Akhtar2, Nandita Perumal1, Brendon Pezzack1 and Abdullah H Baqui23

Author affiliations

1 Department of Paediatrics, Hospital for Sick Children and University of Toronto, 555 University Avenue, Toronto, ON M5G 1X8, Canada

2 International Center for Diarrhoeal Disease Research, Bangladesh (icddr, b), GPO Box 128, Dhaka 1000, Bangladesh

3 Department of International Health, The Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA

For all author emails, please log on.

Citation and License

Nutrition Journal 2013, 12:47  doi:10.1186/1475-2891-12-47

Published: 12 April 2013

Abstract

Background

Antenatal vitamin D status may be associated with the risk of adverse pregnancy and neonatal outcomes; however, the benefits of vitamin D supplementation during pregnancy remain unknown.

Methods

We conducted a double-blind placebo-controlled randomized trial to evaluate the effect of high-dose prenatal 3rd trimester vitamin D3 supplementation on maternal and neonatal (cord blood) serum 25-hydroxyvitamin D (25(OH)D) concentration (primary biochemical efficacy outcome) and maternal serum calcium concentration (primary safety measure). Eligibility criteria were pregnant women aged 18 to <35 years, at 26 to 29 weeks gestation, and residing in Dhaka, Bangladesh. 160 women were randomized by 1:1 allocation to one of two parallel intervention groups; placebo (n = 80) or 35,000 IU/week of vitamin D3 (n = 80) until delivery. All participants, study personnel and study investigators were blind to treatment allocation.

Results

Mean maternal 25(OH)D concentration was similar in the vitamin D and placebo groups at baseline (45 vs. 44 nmol/L; p = 0.66), but was significantly higher in the vitamin D group vs. placebo group among mothers at delivery (134 vs. 38 nmol/L; p < 0.001) and newborns (cord blood: 103 vs. 39; p < 0.001). In the vitamin D group, 95% of neonates and 100% of mothers attained 25(OH)D >50 nmol/L, versus 21% mothers and 19% of neonates in the placebo group. No participants met criteria for hypercalcemia, there were no known supplement-related adverse events, and major pregnancy outcomes were similar between groups.

Conclusions

Antenatal 3rd-trimester vitamin D3 supplementation (35,000 IU/week) significantly raised maternal and cord serum 25(OH)D concentrations above 50 nmol/L in almost all participants without inducing hypercalcemia or other observed safety concerns. Doses up to 35,000 IU/week may be cautiously used in further research aimed at establishing the clinical effects and safety of vitamin D3 supplementation in pregnancy.

Trial registration

This trial was registered at ClinicalTrials.gov (NCT01126528).

Keywords:
Vitamin D; Bangladesh; Pregnancy; Pharmacokinetics; Hypercalcemia