Antenatal Micronutrient Supplementation and Infant Survival

Preterm Birth Clinical Trial

— JiVitA-3  

Official title:

Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860470
• Other study ID #: JHU_IRB 570
• Status: Completed
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: September 2012

Study information

• Verified date: October 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a ~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Birth Weight
• Infant Death
• Infant Mortality
• Low Birth Weight
• Neonatal Mortality
• Perinatal Death
• Perinatal Mortality
• Premature Birth
• Preterm Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bangladesh	JiVitA Project Office	Rangpur	Gaibandha District
United States	Johns Hopkins School of Public Health	Baltimore	Maryland

Sponsors (7)

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)

Countries where clinical trial is conducted

United States,  Bangladesh, 

References & Publications (12)

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

Outcome

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

External Links

•   Basic description of the JiVitA project, location and individuals