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Antenatal Micronutrient Supplementation and Infant Survival (JiVitA-3)

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ClinicalTrials.gov Identifier: NCT00860470
Recruitment Status : Completed
First Posted : March 12, 2009
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
Study Start Date : January 2008
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Infant Mortality Through 6 mo of Age [ Time Frame: Dec 2014 ]
    Risk of Infant Mortality to Age 6 months (180 days)


Secondary Outcome Measures :
  1. Neonatal Mortality [ Time Frame: Dec 2014 ]
    Risk of neonatal Mortality (28 days of life)

  2. Post-neonatal Mortality [ Time Frame: Dec 2014 ]
    Risk of Post-neonatal Mortality (29th -180th day of life)

  3. Still Birth Rates [ Time Frame: December 2014 ]
    Risk of Still birth

  4. Preterm Birth [ Time Frame: December 2014 ]
    Risk of being born before 37 weeks of gestation

  5. Extremely Pre-term [ Time Frame: December 2014 ]
    Risk of birth before 28 weeks gestation

  6. Very Pre-term [ Time Frame: December 2014 ]
    Risk of birth between 28 and 32 weeks of gestation

  7. Moderate to Late Preterm [ Time Frame: December 2014 ]
    Risk of birth between 32 and 37 weeks gestation

  8. Low Birth Weight [ Time Frame: December 2014 ]
    Birth weight below 2500g

  9. Small for Gestation Age [ Time Frame: December 2014 ]
    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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: March 12, 2009    Key Record Dates
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Keith P. West, 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
Infant Death
Perinatal Death
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Death
Pathologic Processes
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamins