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

Daniel E. Roth, Abdullah Al Mahmud, Rubhana Raqib, Evana Akhtar, Nandita Perumal, Brendon Pezzack, Abdullah Baqui

Research output: Contribution to journalArticle

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 3§ssup§rd§esup§ 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 3§ssup§rd§esup§-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).

Original languageEnglish (US)
Article number47
JournalNutrition Journal
Volume12
Issue number1
DOIs
StatePublished - 2013

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Keywords

  • Bangladesh
  • Hypercalcemia
  • Pharmacokinetics
  • Pregnancy
  • Vitamin D

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics
  • Medicine(all)

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