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| Sponsor: | Johns Hopkins Bloomberg School of Public Health |
|---|---|
| Collaborators: |
Bill and Melinda Gates Foundation United States Agency for International Development (USAID) Mahidol University Johns Hopkins University Beximco DSM Nutritional Products, Inc. USAID/ Bangladesh Health and Population Programs(UBHPP) |
| Information provided by: | Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00860470 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant Mortality Preterm Birth Low Birth Weight Neonatal Mortality Perinatal Mortality |
Dietary Supplement: Iron (27 mg) - folic acid (600 ug) Dietary Supplement: Multiple micronutrient |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh |
| Estimated Enrollment: | 36000 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Iron (27 mg) and folic acid (600 ug)
|
Dietary Supplement: Iron (27 mg) - folic acid (600 ug)
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 Name: iron-folate
|
|
Experimental: 2
Multiple micronutrient
|
Dietary Supplement: Multiple micronutrient
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:
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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 36,000 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.
Eligibility| Ages Eligible for Study: | 12 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins School of Public Health | |
| Baltimore, Maryland, United States, 21205 | |
| Bangladesh | |
| JiVitA Project Office | |
| Rangpur, Rangpur District, Bangladesh, 5400 | |
| Principal Investigator: | Keith P West, Jr. | Johns Hopkins Bloomberg School of Public Health |
| Principal Investigator: | Parul Christian | Johns Hopkins Bloomberg School of Public Health |
More Information
| Responsible Party: | Keith P. West, Jr. Professor, Johns Hopkins Bloomberg School of Public Health, Center for Human Nutrition |
| ClinicalTrials.gov Identifier: | NCT00860470 History of Changes |
| Other Study ID Numbers: | JHU_IRB 570 |
| Study First Received: | March 11, 2009 |
| Last Updated: | November 17, 2011 |
| Health Authority: | United States: Institutional Review Board; Bangladesh: Bangladesh Medical Research Council |
|
micronutrients deficiency pregnancy birth outcomes |
infant mortality neonatal mortality malnutrition antenatal |
|
Birth Weight Premature Birth Body Weight Signs and Symptoms Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Folic Acid Iron Micronutrients |
Trace Elements Vitamin B Complex Vitamins Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |