Antenatal Micronutrient Supplementation and Infant Survival (JiVitA-3)

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
Mahidol University
Johns Hopkins University
Beximco
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Keith P. West, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00860470
First received: March 11, 2009
Last updated: December 4, 2013
Last verified: December 2013
  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 3

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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Infant mortality through 6 mo of age [ Time Frame: Dec 2013 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Perinatal mortality, neonatal mortality, birth size (weight, length, circumferences), gestational age at birth, infant health outcomes [ Time Frame: Dec 2013 ] [ Designated as safety issue: Yes ]
  • Maternal morbidity, obstetric complications, body composition, nutritional status [ Time Frame: Dec 2013 ] [ Designated as safety issue: Yes ]

Enrollment: 44567
Study Start Date: January 2008
Study Completion Date: September 2012
Primary Completion Date: September 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:
  • one-a-day multivitamin
  • antenatal micronutrient

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.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860470

Locations
United States, Maryland
Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205
Bangladesh
JiVitA Project Office
Rangpur, Gaibandha District, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
Mahidol University
Johns Hopkins University
Beximco
DSM Nutritional Products, Inc.
Investigators
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

Additional Information:
Publications:

Responsible Party: Keith P. West, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00860470     History of Changes
Other Study ID Numbers: JHU_IRB 570
Study First Received: March 11, 2009
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board
Bangladesh: Bangladesh Medical Research Council

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
micronutrients
deficiency
pregnancy
birth outcomes
infant mortality
neonatal mortality
malnutrition
antenatal

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Birth Weight
Premature Birth
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Iron
Micronutrients
Trace Elements
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014