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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:
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

Tracking Information
First Submitted Date  ICMJE March 11, 2009
First Posted Date  ICMJE March 12, 2009
Results First Submitted Date  ICMJE May 7, 2015
Results First Posted Date  ICMJE May 27, 2015
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE January 2008
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
Infant Mortality Through 6 mo of Age [ Time Frame: Dec 2014 ]
Risk of Infant Mortality to Age 6 months (180 days)
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
Infant Mortality Through 6 mo of Age [ Time Frame: March 2011 ]
Change History Complete list of historical versions of study NCT00860470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Neonatal Mortality [ Time Frame: Dec 2014 ]
    Risk of neonatal Mortality (28 days of life)
  • Post-neonatal Mortality [ Time Frame: Dec 2014 ]
    Risk of Post-neonatal Mortality (29th -180th day of life)
  • Still Birth Rates [ Time Frame: December 2014 ]
    Risk of Still birth
  • Preterm Birth [ Time Frame: December 2014 ]
    Risk of being born before 37 weeks of gestation
  • Extremely Pre-term [ Time Frame: December 2014 ]
    Risk of birth before 28 weeks gestation
  • Very Pre-term [ Time Frame: December 2014 ]
    Risk of birth between 28 and 32 weeks of gestation
  • Moderate to Late Preterm [ Time Frame: December 2014 ]
    Risk of birth between 32 and 37 weeks gestation
  • Low Birth Weight [ Time Frame: December 2014 ]
    Birth weight below 2500g
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
  • Perinatal mortality, neonatal mortality, birth size (weight, length, circumferences), gestational age at birth, infant health outcomes [ Time Frame: March 2011 ]
  • Maternal morbidity, obstetric complications, body composition, nutritional status [ Time Frame: March 2011 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antenatal Micronutrient Supplementation and Infant Survival
Official Title  ICMJE Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Infant Mortality
  • Preterm Birth
  • Low Birth Weight
  • Neonatal Mortality
  • Perinatal Mortality
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Iron (27 mg) and folic acid (600 ug)
    Intervention: Dietary Supplement: Iron (27 mg) - folic acid (600 ug)
  • Experimental: 2
    Multiple micronutrient
    Intervention: Dietary Supplement: Multiple micronutrient
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2013)
44567
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2009)
36000
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00860470
Other Study ID Numbers  ICMJE JHU_IRB 570
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keith P. West, Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • Bill and Melinda Gates Foundation
  • United States Agency for International Development (USAID)
  • Mahidol University
  • Johns Hopkins University
  • Beximco
  • DSM Nutritional Products, Inc.
Investigators  ICMJE
Principal Investigator: Keith P West, Jr. Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Parul Christian Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP