NCT Number: NCT00860470
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.
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Notify Me12 year–45 year
Female
Interventional
Phase 3
JiVitA Project Office, Rangpur City, Gaibandha District, Bangladesh
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: iron-folate
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 names: one-a-day multivitamin, antenatal micronutrient
Time frame: 6-months post-birth
Infant Mortality to Age 6 months (180 days from birth)
Time frame: 1 month post-birth
Neonatal Mortality (28 days of life)
Time frame: 1-6 months post-birth
Risk of Post-neonatal Mortality (29th -180th day of life)
Time frame: 24 weeks gestation to delivery
Stillbirth (born >=24 weeks without breathing, crying, or moving limbs).
Time frame: Up to 37 weeks of gestation
Being born before 37 weeks of gestation
Time frame: Up to 28 weeks of gestation
Birth before 28 weeks gestation
Time frame: Between 27 and 33 weeks of gestation
Birth between 28 and 32 weeks of gestation
Time frame: Between 31 and 38 weeks of gestation
Birth between 32 and 37 weeks gestation
Time frame: Measured at delivery/birth
Birth weight below 2500g
Time frame: At delivery/birth
Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).
Johns Hopkins Bloomberg School of Public Health
Other
Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
Acronym: JiVitA-3
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