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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00860470
Date of registration: 11/03/2009
Prospective Registration: No
Primary sponsor: Johns Hopkins Bloomberg School of Public Health
Public title: Antenatal Micronutrient Supplementation and Infant Survival JiVitA-3
Scientific title: Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
Date of first enrolment: January 2008
Target sample size: 44567
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00860470
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Bangladesh United States
Contacts
Name:     Keith P West, Jr.
Address: 
Telephone:
Email:
Affiliation:  Johns Hopkins Bloomberg School of Public Health
Name:     Parul Christian
Address: 
Telephone:
Email:
Affiliation:  Johns Hopkins Bloomberg School of Public Health
Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 45 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Infant Mortality
Low Birth Weight
Neonatal Mortality
Perinatal Mortality
Preterm Birth
Intervention(s)
Dietary Supplement: Iron (27 mg) - folic acid (600 ug)
Dietary Supplement: Multiple micronutrient
Primary Outcome(s)
Infant Mortality Through 6 mo of Age [Time Frame: Dec 2014]
Secondary Outcome(s)
Extremely Pre-term [Time Frame: December 2014]
Low Birth Weight [Time Frame: December 2014]
Moderate to Late Preterm [Time Frame: December 2014]
Neonatal Mortality [Time Frame: Dec 2014]
Post-neonatal Mortality [Time Frame: Dec 2014]
Preterm Birth [Time Frame: December 2014]
Small for Gestation Age [Time Frame: December 2014]
Still Birth Rates [Time Frame: December 2014]
Very Pre-term [Time Frame: December 2014]
Secondary ID(s)
JHU_IRB 570
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Beximco
Bill and Melinda Gates Foundation
DSM Nutritional Products, Inc.
Johns Hopkins University
Mahidol University
United States Agency for International Development (USAID)
Ethics review
Results
Results available: Yes
Date Posted: 27/05/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00860470
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