Antenatal Micronutrient Supplementation and Infant Survival

• Register: ClinicalTrials.gov
• Last refreshed on: 31 October 2022
• 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: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bangladesh, United States

Contacts

• Name: Keith P West, Jr.
• Affiliation: Johns Hopkins Bloomberg School of Public Health

• Name: Parul Christian
• 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

Perinatal Mortality

Neonatal Mortality

Low Birth Weight

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: 6-months post-birth]

Secondary Outcome(s)

Preterm Birth [Time Frame: Up to 37 weeks of gestation]

Extremely Pre-term [Time Frame: Up to 28 weeks of gestation]

Neonatal Mortality [Time Frame: 1 month post-birth]

Small for Gestation Age [Time Frame: At delivery/birth]

Moderate to Late Preterm [Time Frame: Between 31 and 38 weeks of gestation]

Post-neonatal Mortality [Time Frame: 1-6 months post-birth]

Still Birth Rates [Time Frame: 24 weeks gestation to delivery]

Low Birth Weight [Time Frame: Measured at delivery/birth]

Very Pre-term [Time Frame: Between 27 and 33 weeks of gestation]

Secondary ID(s)

JHU_IRB 570

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DSM Nutritional Products, Inc.

Mahidol University

Beximco Pharmaceuticals Ltd.

Bill and Melinda Gates Foundation

Johns Hopkins University

United States Agency for International Development (USAID)

Results

• Results available: Yes
• Date Posted: 27/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00860470