Effect of Maternal multiple micronutrient vs iron-folic acid supplementation on infant mortality and adverse birth outcomes in rural Bangladesh: The JiVitA-3 randomized trial

Keith P. West, Abu Ahmed Shamim, Sucheta Mehra, Alain B. Labrique, Hasmot Ali, Saijuddin Shaikh, Rolf D.W. Klemm, Lee S.F. Wu, Maithilee Mitra, Rezwanul Haque, Abu A.M. Hanif, Allan B. Massie, Rebecca Day Merrill, Kerry J. Schulze, Parul Christian

Research output: Contribution to journalArticle

Abstract

IMPORTANCE: Maternal micronutrient deficienciesmay adversely affect fetal and infant health, yet there is insufficient evidence of effects on these outcomes to guide antenatal micronutrient supplementation in South Asia.

OBJECTIVE: To assess effects of antenatal multiple micronutrient vs iron-folic acid supplementation on 6-month infant mortality and adverse birth outcomes.

DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized, double-masked trial in Bangladesh, with pregnancy surveillance starting December 4, 2007, and recruitment on January 11,2008.Six-month infant follow-up ended August 30, 2012. Surveillance included 127 282 women; 44 567 became pregnant and were included in the analysis and delivered 28 516 live-born infants. Median gestation at enrollment was 9 weeks (interquartile range, 7-12).

INTERVENTIONS: Women were provided supplements containing 15 micronutrients or iron-folic acid alone, taken daily from early pregnancy to 12 weeks postpartum.

MAIN OUTCOMES AND MEASURES: The primary outcomewas all-cause infant mortality through 6 months (180 days). Prespecified secondary outcomes in this analysis included stillbirth, preterm birth (<37 weeks), and low birth weight (<2500 g). To maintain overall significance of α =.05, a Bonferroni-corrected α =.01 was calculated to evaluate statistical significance of primary and 4 secondary risk outcomes (.05/5).

RESULTS: Among the 22 405 pregnancies in the multiple micronutrient group and the 22 162 pregnancies in the iron-folic acid group, there were 14 374 and 14 142 live-born infants, respectively, included in the analysis. At 6 months, multiple micronutrients did not significantly reduce infant mortality; there were 764 deaths (54.0 per 1000 live births) in the iron-folic acid group and 741 deaths (51.6 per 1000 live births) in the multiple micronutrient group (relative risk [RR], 0.95; 95%CI, 0.86-1.06). Multiple micronutrient supplementation resulted in a non-statistically significant reduction in stillbirths (43.1 vs 48.2 per 1000 births; RR, 0.89; 95%CI, 0.81-0.99; P =.02) and significant reductions in preterm births (18.6 vs 21.8 per 100 live births; RR, 0.85; 95%CI, 0.80-0.91; P <.001) and low birth weight (40.2 vs 45.7 per 100 live births; RR, 0.88; 95%CI, 0.85-0.91; P <.001).

CONCLUSIONS AND RELEVANCE: In Bangladesh, antenatal multiple micronutrient compared with iron-folic acid supplementation did not reduce all-cause infant mortality to age 6 months but resulted in a non-statistically significant reduction in stillbirths and significant reductions in preterm births and low birth weight.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00860470.

Original languageEnglish (US)
Pages (from-to)2649-2658
Number of pages10
JournalJAMA - Journal of the American Medical Association
Volume312
Issue number24
DOIs
StatePublished - Dec 24 2014

    Fingerprint

ASJC Scopus subject areas

  • Medicine(all)

Cite this