(17-06-13) Randomized placebo-controlled trial of high-dose

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 Baqui2,3


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.

Source: Roth et al. Nutrition Journal 2013, 12:47
http://www.nutritionj.com/content/12/1/47

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