Antenatal Micronutrient Supplementation and Infant Survival (JiVitA-3)

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3

Conditions: Infant Mortality; Perinatal Mortality; Neonatal Mortality; Low Birth Weight; Preterm Birth

Treatments: Dietary Supplement: Iron (27 mg) - folic acid (600 ug); Dietary Supplement: Multiple micronutrient

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00860470

JHU_IRB 570

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44,567 patients

Sex: Female

Ages: 12 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant and consents to participate

Exclusion criteria

• Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44,567 participants in 2 patient groups

1

Active Comparator group

Description:

Iron (27 mg) and folic acid (600 ug)

Treatment:

Dietary Supplement: Iron (27 mg) - folic acid (600 ug)

2

Experimental group

Description:

Multiple micronutrient

Treatment:

Dietary Supplement: Multiple micronutrient