Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin A Deficiency; Maternal Mortality; Infant Mortality
Intervention: Vitamin A or Beta-Carotene Supplements (Dietary Supplement)
Phase: Phase 3
Status: Completed
Sponsored by: Johns Hopkins Bloomberg School of Public Health Official(s) and/or principal investigator(s): Keith P West, Jr., Dr.P.H., Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health Parul Christian, Dr.P.H., Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health Rolf DW Klemm, Dr.P.H., Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health Mahbubur Rashid, MBBS, MSc, Study Director, Affiliation: JiVitA Bangladesh Project Alain B Labrique, MSc, Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health Alfred Sommer, M.D., Study Director, Affiliation: Johns Hopkins Bloomberg School of Public Health
Summary
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.
Clinical Details
Official title: Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: All-cause, Pregnancy-related Mortality
Secondary outcome: All-cause 3-month Infant MortalityMaternal Morbidity, Including Obstetric Complications Gestational Age at Birth Fetal Growth and Postnatal Infant Growth Through Three Months of Age Infant Morbidity Through 3 Months of Age Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother) Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)
Detailed description:
Maternal mortality and vitamin A deficiency coexist in rural South Asia. In Nepal, weekly
supplementation with vitamin A or beta-carotene during the child-bearing years reduced
all-cause maternal mortality and, in night blind women, also infant mortality. The present
trial is testing the efficacy of the same supplements from ~9 weeks' gestation to 12 weeks
postpartum. The planned sample size is 68,000 pregnancies. It is being conducted in 19
rural unions, covering an area of ~750 sq km with a population of ~580,000 in Gaibandha and
Southern Rangpur Districts in Northern Bangladesh. The study area was mapped as 596
"sectors" (unit of randomization), each comprising 200-275 households; ~135,000 houses were
numerically addressed and, at the outset, 103,000 women were listed. Women are visited at
home every 5 weeks by 596 trained female staff to detect pregnancy by a combination of
menstrual history and urine testing. Newly married women are prospectively enlisted for
pregnancy surveillance. Following informed consent urine-positive (pregnant) women detected
during surveillance are enrolled to receive weekly a capsule containing 7000 retinol
equivalents of preformed vitamin A, 42 mg of beta-carotene or placebo. Vital events are
recorded weekly through 3 months postpartum. Trained interviewers conduct maternal
nutritional and health and household socioeconomic assessments in the 1st trimester. At 3
months postpartum, interviewers assess both mother and infant for health and nutritional
status, including apparent birth defects that are later physician-confirmed. An additional
home health assessment occurs at 6 months post partum, and vital status is recorded for
mother and infant at one year postpartum. A ~3% subsample of enrolled pregnant women
participate in a substudy involving enhanced clinical, anthropometric, biochemical, body
compositional, morbidity and interview-based assessment protocols in the 1st, 2nd and 3rd
trimesters, and at 3 months post-partum. Reported maternal and infant deaths are verified
and causes ascertained during "verbal autopsy" interviews with family members of the
deceased.
Eligibility
Minimum age: 15 Years.
Maximum age: 49 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Johns Hopkins School of Public Health, Baltimore, Maryland 21205, United States
JiVitA Bangladesh Project, Rangpur, Rajshahi Division, Bangladesh
JiVitA Project Office, Rangpur, Rangpur District 5400, Bangladesh
Additional Information
Micronutrient research at the Center for Human Nutrition at Johns Hopkins Bloomberg School of Public Health
Related publications: 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. 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. 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. 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. 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. 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.
Starting date: August 2001
Last updated: March 5, 2012
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