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 : October 19, 2022
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44567 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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
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.
- Infant Mortality Through 6 mo of Age [ Time Frame: 6-months post-birth ]Infant Mortality to Age 6 months (180 days from birth)
- Neonatal Mortality [ Time Frame: 1 month post-birth ]Neonatal Mortality (28 days of life)
- Post-neonatal Mortality [ Time Frame: 1-6 months post-birth ]Risk of Post-neonatal Mortality (29th -180th day of life)
- Still Birth Rates [ Time Frame: 24 weeks gestation to delivery ]Stillbirth (born >=24 weeks without breathing, crying, or moving limbs).
- Preterm Birth [ Time Frame: Up to 37 weeks of gestation ]Being born before 37 weeks of gestation
- Extremely Pre-term [ Time Frame: Up to 28 weeks of gestation ]Birth before 28 weeks gestation
- Very Pre-term [ Time Frame: Between 27 and 33 weeks of gestation ]Birth between 28 and 32 weeks of gestation
- Moderate to Late Preterm [ Time Frame: Between 31 and 38 weeks of gestation ]Birth between 32 and 37 weeks gestation
- Low Birth Weight [ Time Frame: Measured at delivery/birth ]Birth weight below 2500g
- Small for Gestation Age [ Time Frame: At delivery/birth ]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).
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
|United States, Maryland|
|Johns Hopkins School of Public Health|
|Baltimore, Maryland, United States, 21205|
|JiVitA Project Office|
|Rangpur, Gaibandha District, Bangladesh|
|Principal Investigator:||Keith P West, Jr.||Johns Hopkins Bloomberg School of Public Health|
|Principal Investigator:||Parul Christian||Johns Hopkins Bloomberg School of Public Health|