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

Nutrition Journal

Abdullah H Baqui²  Brendon Pezzack³  Nandita Perumal³  Evana Akhtar¹  Rubhana Raqib¹  Abdullah Al Mahmud¹  Daniel E Roth³ 

[1] International Center for Diarrhoeal Disease Research, Bangladesh (icddr, b), GPO Box 128, Dhaka 1000, Bangladesh;Department of International Health, The Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA;Department of Paediatrics, Hospital for Sick Children and University of Toronto, 555 University Avenue, Toronto, ON M5G 1X8, Canada

关键词: Hypercalcemia;    Pharmacokinetics;    Pregnancy;    Bangladesh;    Vitamin D;   

Others  :  806946
DOI  :  10.1186/1475-2891-12-47

 received in 2012-12-27, accepted in 2013-03-26,  发布年份 2013

【 摘 要 】

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 3^rd 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 3^rd-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).

【 授权许可】

   
2013 Roth et al.; licensee BioMed Central Ltd.

【 图 表 】

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