Abstract
BackgroundAntenatal 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.MethodsWe 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.ResultsMean 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.ConclusionsAntenatal 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 registrationThis trial was registered at ClinicalTrials.gov (NCT01126528).
Highlights
Vitamin D status during pregnancy has been proposed to influence the risk of gestational diabetes and hypertensive diseases of pregnancy [1], fetal skeletal growth [2], brain development [3], and neonatal immune function [4]
The Institute of Medicine (IOM) Committee to Review Dietary Reference Intakes (DRIs) for Vitamin D and Creatinine Ratio (Calcium) concluded in 2010 that the recommended dietary allowance (RDA) of 600 International Units (IU)/day and tolerable upper intake level (UL) of 4000 IU/day for non-pregnant adults were suitable for pregnant women [7]
Participants were screened for eligibility when they presented to the clinic for antenatal care (ANC) visits during regular daytime clinic hours, and were offered enrolment if they met the following inclusion criteria: aged 18 to
Summary
Vitamin D status during pregnancy has been proposed to influence the risk of gestational diabetes and hypertensive diseases of pregnancy [1], fetal skeletal growth [2], brain development [3], and neonatal immune function [4]. The safety of highdose prenatal vitamin D regimens The UL was doubled from 2000 IU/ day, as recommended by the IOM in 1997 [10], despite a lack of new pregnancy trial safety data published between 1997 and 2010. Uncertainty surrounding vitamin D requirements in pregnancy has led to divergent dose recommendations; for example, the UNICEF antenatal micronutrient formulation contains 200 IU/day [11], the Canadian Paediatric Society has suggested 2000 IU/day [12], and Hollis et al advised an intake of 4000 IU/day [13]. Antenatal vitamin D status may be associated with the risk of adverse pregnancy and neonatal outcomes; the benefits of vitamin D supplementation during pregnancy remain unknown
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