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Antenatal Micronutrient Supplementation and Infant Survival (JiVitA-3)
This study is currently recruiting participants.
Verified by Johns Hopkins Bloomberg School of Public Health, July 2009
First Received: March 11, 2009   Last Updated: July 14, 2009   History of Changes
Sponsors and Collaborators: Johns Hopkins Bloomberg School of Public Health
Bill and Melinda Gates Foundation
US Agency for International Development
Mahidol University
Johns Hopkins University
Beximco
DSM Ltd.
UBHPP-USAID/Bangladesh Health and Population Programs
Information provided by: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00860470
  Purpose

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.


Condition Intervention 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 III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Infant mortality through 6 mo of age [ Time Frame: March 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Perinatal mortality, neonatal mortality, birth size (weight, length, circumferences), gestational age at birth, infant health outcomes [ Time Frame: March 2011 ] [ Designated as safety issue: Yes ]
  • Maternal morbidity, obstetric complications, body composition, nutritional status [ Time Frame: March 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36000
Study Start Date: January 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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.

2: Experimental
Multiple micronutrient
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.

Detailed 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 36,000 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.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860470

Contacts
Contact: Keith P West, Jr. 410-955-2061 kwest@jhsph.edu

Locations
United States, Maryland
Johns Hopkins School of Public Health Recruiting
Baltimore, Maryland, United States, 21205
Contact: Keith P West Jr., DrPH     410-955-2061     kwest@jhsph.edu    
Contact: Parul Christian, DrPH     410-955-1188     pchristi@jhsph.edu    
Principal Investigator: Keith P West Jr., DrPH            
Principal Investigator: Parul Christian, DrPH            
Sub-Investigator: Rolf Klemm, DrPH            
Sub-Investigator: Alain Labrique, PhD            
Sub-Investigator: Kerry Schulze, PhD            
Sub-Investigator: Joanne Katz, ScD            
Bangladesh, Rangpur District
JiVitA Project Office Recruiting
Rangpur, Rangpur District, Bangladesh, 5400
Contact: Mahbubur Rashid, MBBS     880-0521-61473/63391     mrashid.jivita@gmail.com    
Sub-Investigator: Mahbubur Rashid            
Sub-Investigator: Abu Ahmed Shamim            
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Bill and Melinda Gates Foundation
US Agency for International Development
Mahidol University
Johns Hopkins University
Beximco
DSM Ltd.
UBHPP-USAID/Bangladesh Health and Population Programs
Investigators
Principal Investigator: Keith P West, Jr. Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Parul Christian Johns Hopkins Bloomberg School of Public Health
  More Information

Additional Information:
Publications:
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.
Christian P. Micronutrients and reproductive health issues: an international perspective. J Nutr. 2003 Jun;133(6):1969S-1973S. Review.
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.
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.
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.
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.
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. No abstract available.
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.
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.
West KP Jr, Christian P. Antenatal micronutrients in undernourished people. Lancet. 2008 Feb 9;371(9611):452-4. No abstract available.
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.
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.

Responsible Party: Johns Hopkins Bloomberg School of Public Health, Center for Human Nutrition ( Keith P. West, Jr. Professor )
Study ID Numbers: JHU_IRB 570
Study First Received: March 11, 2009
Last Updated: July 14, 2009
ClinicalTrials.gov Identifier: NCT00860470     History of Changes
Health Authority: United States: Institutional Review Board;   Bangladesh: Bangladesh Medical Research Council

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
micronutrients
deficiency
pregnancy
birth outcomes
infant mortality
neonatal mortality
malnutrition
antenatal

Study placed in the following topic categories:
Obstetric Labor, Premature
Tocopherol
Copper
Vitamin B 6
Nicotinamide
Body Weight
Iodine
Nicotinic Acid
Tocopherol acetate
Cyanocobalamin
Hydroxocobalamin
Thiamine
Cobalamin
Alpha-Tocopherol
Folic Acid
Vitamin C
Vitamin B1
Vitamin E
Vitamin B2
Vitamin B3
Vitamin D
Vitamin B12
Vitamin A
Pyridoxine
Iron
Niacin
Ascorbic Acid
Pregnancy Complications
Niacinamide
Folate

Additional relevant MeSH terms:
Birth Weight
Pregnancy Complications
Vitamin B Complex
Hematinics
Obstetric Labor, Premature
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Obstetric Labor Complications
Trace Elements
Pharmacologic Actions
Body Weight
Folic Acid
Signs and Symptoms
Therapeutic Uses
Vitamins
Micronutrients
Premature Birth

ClinicalTrials.gov processed this record on September 10, 2009