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 West, Abu Ahmed Shamim, Sucheta Mehra, Alain B Labrique, Hasmot Ali, Saijuddin Shaikh, Rolf Klemm, Lee Shu Fune Wu, Maithilee Mitra, Rezwanul Haque, Abu A M Hanif, Allan B Massie, Rebecca Day Merrill, Kerry J Schulze, Parul S 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 (

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

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
JournalJournal of the American Medical Association
Volume312
Issue number24
DOIs
StatePublished - Dec 24 2014

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Bangladesh
Micronutrients
Infant Mortality
Folic Acid
Iron
Mothers
Parturition
Stillbirth
Premature Birth
Live Birth
Pregnancy
Multiple Pregnancy
Low Birth Weight Infant
Postpartum Period

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{da04dc29d9b14f449b9b1b1929664374,
title = "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",
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 (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 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.",
author = "Keith West and Shamim, {Abu Ahmed} and Sucheta Mehra and Labrique, {Alain B} and Hasmot Ali and Saijuddin Shaikh and Rolf Klemm and Wu, {Lee Shu Fune} and Maithilee Mitra and Rezwanul Haque and Hanif, {Abu A M} and Massie, {Allan B} and Merrill, {Rebecca Day} and Schulze, {Kerry J} and Christian, {Parul S}",
year = "2014",
month = "12",
day = "24",
doi = "10.1001/jama.2014.16819",
language = "English (US)",
volume = "312",
pages = "2649--2658",
journal = "JAMA - Journal of the American Medical Association",
issn = "0098-7484",
publisher = "American Medical Association",
number = "24",

}

TY - JOUR

T1 - Effect of Maternal multiple micronutrient vs iron-folic acid supplementation on infant mortality and adverse birth outcomes in rural Bangladesh

T2 - The JiVitA-3 randomized trial

AU - West, Keith

AU - Shamim, Abu Ahmed

AU - Mehra, Sucheta

AU - Labrique, Alain B

AU - Ali, Hasmot

AU - Shaikh, Saijuddin

AU - Klemm, Rolf

AU - Wu, Lee Shu Fune

AU - Mitra, Maithilee

AU - Haque, Rezwanul

AU - Hanif, Abu A M

AU - Massie, Allan B

AU - Merrill, Rebecca Day

AU - Schulze, Kerry J

AU - Christian, Parul S

PY - 2014/12/24

Y1 - 2014/12/24

N2 - 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 (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 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.

AB - 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 (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 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.

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U2 - 10.1001/jama.2014.16819

DO - 10.1001/jama.2014.16819

M3 - Article

VL - 312

SP - 2649

EP - 2658

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0098-7484

IS - 24

ER -