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

  • Roth D
  • Al Mahmud A
  • Raqib R
 et al. 
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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 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).

Author-supplied keywords

  • Bangladesh
  • Hypercalcemia
  • Pharmacokinetics
  • Pregnancy
  • Vitamin D

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Authors

  • LAURA ESTESO JUANCatholic University of Valenica San Carlos Borromeo Campus

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  • Abdullah Al Mahmud

  • Rubhana Raqib

  • Evana Akhtar

  • Nandita Perumal

  • Brendon Pezzack

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