Antenatal Micronutrient Supplementation and Infant Survival
Condition: Infant Mortality; Preterm Birth; Low Birth Weight; Neonatal Mortality; Perinatal Mortality
MeSH terms: Premature Birth; Perinatal Death; Birth Weight; Infant Death
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this community-based randomized trial is to examine whether a daily antenatal
      and postnatal multiple micronutrient supplement given to women will enhance newborn and
      infant survival and health and other birth outcomes in a rural setting in northwestern
      Bangladesh.
    

Detailed description: 
      Maternal deficiency in multiple essential micronutrients is likely to be a major public
      health problem in low-income countries. Supplementing mothers with certain individual
      micronutrients has been shown to confer health benefits, although the evidence is not clear
      for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked,
      controlled trial whether giving a daily multiple micronutrient supplement (similar in
      composition to the UNICEF antenatal supplement) will enhance infant survival and birth
      outcomes such as birth weight and gestational duration in a rural population in Bangladesh.
      Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts
      of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant
      women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement
      them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the
      standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and
      vital status and health of liveborn infants through 6 months of age. In a ~3% sub-sample of
      mothers, additional measures of nutritional and health status will be evaluated in the 1st
      and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include
      anthropometric and body composition (bioelectrical impedance) assessment, collection of
      biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte
      concentration determinations), and other clinical assessments. The trial will generate
      evidence from which to examine the safety and efficacy of an antenatal through postnatal
      maternal micronutrient supplement intervention in order to inform and guide antenatal
      nutrition policies and programs in South Asia.
    

Intervention name(s): Iron (27 mg) - folic acid (600 ug); Multiple micronutrient
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.; Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
Other intervention name(s): iron-folate; one-a-day multivitamin; antenatal micronutrient
Intervention MeSH terms: Iron; Trace Elements; Folic Acid; Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: micronutrients; deficiency; pregnancy; birth outcomes; infant mortality; neonatal mortality; malnutrition; antenatal