Preterm Birth Clinical Trial
— JiVitA-3Official title:
Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
Verified date | October 2022 |
Source | Johns Hopkins Bloomberg School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44567 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 12 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bangladesh | JiVitA Project Office | Rangpur | Gaibandha District |
United States | Johns Hopkins School of Public Health | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | Beximco Pharmaceuticals Ltd., Bill and Melinda Gates Foundation, DSM Nutritional Products, Inc., Johns Hopkins University, Mahidol University, United States Agency for International Development (USAID) |
United States, Bangladesh,
Christian P, Darmstadt GL, Wu L, Khatry SK, Leclerq SC, Katz J, West KP Jr, Adhikari RK. The effect of maternal micronutrient supplementation on early neonatal morbidity in rural Nepal: a randomised, controlled, community trial. Arch Dis Child. 2008 Aug;93(8):660-4. doi: 10.1136/adc.2006.114009. — View Citation
Christian P, Jiang T, Khatry SK, LeClerq SC, Shrestha SR, West KP Jr. Antenatal supplementation with micronutrients and biochemical indicators of status and subclinical infection in rural Nepal. Am J Clin Nutr. 2006 Apr;83(4):788-94. — View Citation
Christian P, Khatry SK, Katz J, Pradhan EK, LeClerq SC, Shrestha SR, Adhikari RK, Sommer A, West KP Jr. Effects of alternative maternal micronutrient supplements on low birth weight in rural Nepal: double blind randomised community trial. BMJ. 2003 Mar 15;326(7389):571. — View Citation
Christian P, Osrin D, Manandhar DS, Khatry SK, de L Costello AM, West KP Jr. Antenatal micronutrient supplements in Nepal. Lancet. 2005 Aug 27-Sep 2;366(9487):711-2. — View Citation
Christian P, Shrestha J, LeClerq SC, Khatry SK, Jiang T, Wagner T, Katz J, West KP Jr. Supplementation with micronutrients in addition to iron and folic acid does not further improve the hematologic status of pregnant women in rural Nepal. J Nutr. 2003 Nov;133(11):3492-8. — View Citation
Christian P, West KP, Khatry SK, Leclerq SC, Pradhan EK, Katz J, Shrestha SR, Sommer A. Effects of maternal micronutrient supplementation on fetal loss and infant mortality: a cluster-randomized trial in Nepal. Am J Clin Nutr. 2003 Dec;78(6):1194-202. — View Citation
Christian P. Micronutrients and reproductive health issues: an international perspective. J Nutr. 2003 Jun;133(6):1969S-1973S. Review. — View Citation
Jiang T, Christian P, Khatry SK, Wu L, West KP Jr. Micronutrient deficiencies in early pregnancy are common, concurrent, and vary by season among rural Nepali pregnant women. J Nutr. 2005 May;135(5):1106-12. — View Citation
Katz J, Christian P, Dominici F, Zeger SL. Treatment effects of maternal micronutrient supplementation vary by percentiles of the birth weight distribution in rural Nepal. J Nutr. 2006 May;136(5):1389-94. — View Citation
Katz J, West KP Jr, Khatry SK, Christian P, LeClerq SC, Pradhan EK, Shrestha SR. Risk factors for early infant mortality in Sarlahi district, Nepal. Bull World Health Organ. 2003;81(10):717-25. Epub 2003 Nov 25. — View Citation
Shankar AH, Genton B, Baisor M, Paino J, Tamja S, Adiguma T, Wu L, Rare L, Bannon D, Tielsch JM, West KP Jr, Alpers MP. The influence of zinc supplementation on morbidity due to Plasmodium falciparum: a randomized trial in preschool children in Papua New Guinea. Am J Trop Med Hyg. 2000 Jun;62(6):663-9. — View Citation
West KP Jr, Christian P. Antenatal micronutrients in undernourished people. Lancet. 2008 Feb 9;371(9611):452-4. doi: 10.1016/S0140-6736(08)60214-7. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infant Mortality Through 6 mo of Age | Infant Mortality to Age 6 months (180 days from birth) | 6-months post-birth | |
Secondary | Neonatal Mortality | Neonatal Mortality (28 days of life) | 1 month post-birth | |
Secondary | Post-neonatal Mortality | Risk of Post-neonatal Mortality (29th -180th day of life) | 1-6 months post-birth | |
Secondary | Still Birth Rates | Stillbirth (born >=24 weeks without breathing, crying, or moving limbs). | 24 weeks gestation to delivery | |
Secondary | Preterm Birth | Being born before 37 weeks of gestation | Up to 37 weeks of gestation | |
Secondary | Extremely Pre-term | Birth before 28 weeks gestation | Up to 28 weeks of gestation | |
Secondary | Very Pre-term | Birth between 28 and 32 weeks of gestation | Between 27 and 33 weeks of gestation | |
Secondary | Moderate to Late Preterm | Birth between 32 and 37 weeks gestation | Between 31 and 38 weeks of gestation | |
Secondary | Low Birth Weight | Birth weight below 2500g | Measured at delivery/birth | |
Secondary | Small for Gestation Age | 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). | At delivery/birth |
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