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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Iron (27 mg) and folic acid (600 ug)
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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
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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:
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- Infant Mortality Through 6 mo of Age [ Time Frame: Dec 2014 ]Risk of Infant Mortality to Age 6 months (180 days)
- 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).

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Ages Eligible for Study: | 12 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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 | |
Bangladesh | |
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 |
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:
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 Folic Acid Micronutrients Vitamin B Complex Growth Substances Physiological Effects of Drugs Hematinics Vitamins |