Vitamin A Deficiency Clinical Trial
Official title:
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.
Status | Completed |
Enrollment | 59666 |
Est. completion date | March 2008 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Married women of reproductive age - First pregnancy during time period of trial Exclusion Criteria: - Premenarchial girls - Married women with a previous pregnancy enrolled into the trial - Previously married women who have moved into the study area - Single women (never married, widowers) - Women who are sterilized (or whose husbands are sterilized) - Menopausal women |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Bangladesh | JiVitA Bangladesh Project | Rangpur | Rajshahi Division |
Bangladesh | JiVitA Project Office | Rangpur | Rangpur District |
United States | Johns Hopkins School of Public Health | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | Access Business Group, Bill and Melinda Gates Foundation, Canadian International Development Agency, The Sight and Life Research Institute, United States Agency for International Development (USAID) |
United States, Bangladesh,
Christian P, West KP Jr, Khatry SK, Katz J, LeClerq SC, Kimbrough-Pradhan E, Dali SM, Shrestha SR. Vitamin A or beta-carotene supplementation reduces symptoms of illness in pregnant and lactating Nepali women. J Nutr. 2000 Nov;130(11):2675-82. — View Citation
Christian P, West KP Jr, Khatry SK, Kimbrough-Pradhan E, LeClerq SC, Katz J, Shrestha SR, Dali SM, Sommer A. Night blindness during pregnancy and subsequent mortality among women in Nepal: effects of vitamin A and beta-carotene supplementation. Am J Epidemiol. 2000 Sep 15;152(6):542-7. — View Citation
Christian P, West KP Jr, Khatry SK, LeClerq SC, Kimbrough-Pradhan E, Katz J, Shrestha SR. Maternal night blindness increases risk of mortality in the first 6 months of life among infants in Nepal. J Nutr. 2001 May;131(5):1510-2. — View Citation
Gunnsteinsson S, Labrique AB, West KP Jr, Christian P, Mehra S, Shamim AA, Rashid M, Katz J, Klemm RD. Constructing indices of rural living standards in Northwestern Bangladesh. J Health Popul Nutr. 2010 Oct;28(5):509-19. — View Citation
Katz J, West KP Jr, Khatry SK, Pradhan EK, LeClerq SC, Christian P, Wu LS, Adhikari RK, Shrestha SR, Sommer A. Maternal low-dose vitamin A or beta-carotene supplementation has no effect on fetal loss and early infant mortality: a randomized cluster trial in Nepal. Am J Clin Nutr. 2000 Jun;71(6):1570-6. — View Citation
Labrique AB, Christian P, Klemm RD, Rashid M, Shamim AA, Massie A, Schulze K, Hackman A, West KP Jr. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods. Trials. 2011 Apr 21 — View Citation
West KP Jr, Christian P, Labrique AB, Rashid M, Shamim AA, Klemm RD, Massie AB, Mehra S, Schulze KJ, Ali H, Ullah B, Wu LS, Katz J, Banu H, Akhter HH, Sommer A. Effects of vitamin A or beta carotene supplementation on pregnancy-related mortality and infan — View Citation
West KP Jr, Katz J, Khatry SK, LeClerq SC, Pradhan EK, Shrestha SR, Connor PB, Dali SM, Christian P, Pokhrel RP, Sommer A. Double blind, cluster randomised trial of low dose supplementation with vitamin A or beta carotene on mortality related to pregnancy in Nepal. The NNIPS-2 Study Group. BMJ. 1999 Feb 27;318(7183):570-5. — View Citation
West KP Jr. Extent of vitamin A deficiency among preschool children and women of reproductive age. J Nutr. 2002 Sep;132(9 Suppl):2857S-2866S. Erratum in: J Nutr 2002 Nov;132(11):3432. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause, Pregnancy-related Mortality | Mortality evaluated on intent-to-treat basis | Deaths during pregnancy through 12 weeks postpartum | No |
Secondary | All-cause 3-month Infant Mortality | Deaths through the 1st 12 weeks of life | No | |
Secondary | Maternal Morbidity, Including Obstetric Complications | through the 1st 24 weeks following termination of pregnancy | No | |
Secondary | Gestational Age at Birth | within 24 weeks after birth | No | |
Secondary | Fetal Growth and Postnatal Infant Growth Through Three Months of Age | through the 1st 12 weeks after birth | No | |
Secondary | Infant Morbidity Through 3 Months of Age | within 24 weeks after birth | No | |
Secondary | Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother) | Third trimester of pregnancy (about the 32nd week of gesatation) | No | |
Secondary | Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother) | Third trimester of pregnancy (about the 32nd week of gestation) | No |
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