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Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health Bill and Melinda Gates Foundation US Agency for International Development Mahidol University Johns Hopkins University Beximco DSM Ltd. UBHPP-USAID/Bangladesh Health and Population Programs |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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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: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Iron (27 mg) and folic acid (600 ug)
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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. |
2: Experimental
Multiple micronutrient
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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.
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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.
Ages Eligible for Study: | 12 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Keith P West, Jr. | 410-955-2061 | kwest@jhsph.edu |
United States, Maryland | |
Johns Hopkins School of Public Health | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Keith P West Jr., DrPH 410-955-2061 kwest@jhsph.edu | |
Contact: Parul Christian, DrPH 410-955-1188 pchristi@jhsph.edu | |
Principal Investigator: Keith P West Jr., DrPH | |
Principal Investigator: Parul Christian, DrPH | |
Sub-Investigator: Rolf Klemm, DrPH | |
Sub-Investigator: Alain Labrique, PhD | |
Sub-Investigator: Kerry Schulze, PhD | |
Sub-Investigator: Joanne Katz, ScD | |
Bangladesh, Rangpur District | |
JiVitA Project Office | Recruiting |
Rangpur, Rangpur District, Bangladesh, 5400 | |
Contact: Mahbubur Rashid, MBBS 880-0521-61473/63391 mrashid.jivita@gmail.com | |
Sub-Investigator: Mahbubur Rashid | |
Sub-Investigator: Abu Ahmed Shamim |
Principal Investigator: | Keith P West, Jr. | Johns Hopkins Bloomberg School of Public Health |
Principal Investigator: | Parul Christian | Johns Hopkins Bloomberg School of Public Health |
Responsible Party: | Johns Hopkins Bloomberg School of Public Health, Center for Human Nutrition ( Keith P. West, Jr. Professor ) |
Study ID Numbers: | JHU_IRB 570 |
Study First Received: | March 11, 2009 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00860470 History of Changes |
Health Authority: | United States: Institutional Review Board; Bangladesh: Bangladesh Medical Research Council |
micronutrients deficiency pregnancy birth outcomes |
infant mortality neonatal mortality malnutrition antenatal |
Obstetric Labor, Premature Tocopherol Copper Vitamin B 6 Nicotinamide Body Weight Iodine Nicotinic Acid Tocopherol acetate Cyanocobalamin Hydroxocobalamin Thiamine Cobalamin Alpha-Tocopherol Folic Acid |
Vitamin C Vitamin B1 Vitamin E Vitamin B2 Vitamin B3 Vitamin D Vitamin B12 Vitamin A Pyridoxine Iron Niacin Ascorbic Acid Pregnancy Complications Niacinamide Folate |
Birth Weight Pregnancy Complications Vitamin B Complex Hematinics Obstetric Labor, Premature Growth Substances Hematologic Agents Physiological Effects of Drugs Obstetric Labor Complications |
Trace Elements Pharmacologic Actions Body Weight Folic Acid Signs and Symptoms Therapeutic Uses Vitamins Micronutrients Premature Birth |