TY - JOUR
T1 - A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh
T2 - Design and methods
AU - Labrique, Alain B.
AU - Christian, Parul
AU - Klemm, Rolf D.W.
AU - Rashid, Mahbubur
AU - Shamim, Abu A.
AU - Massie, Allan
AU - Schulze, Kerry
AU - Hackman, Andre
AU - West, Keith P.
N1 - Funding Information:
We gratefully acknowledge the contributions over a period of seven years of more than 850 dedicated local supplement distributors, interviewers, research physicians, data management staff, and study managers and administrators, including Drs. Barkat Ullah and Hasmot Ali, Mr. Abdul Jabbar, Mr. Azaduzzaman, Mr. Rezwanul Haque, Mrs. Nusrat Jahan and Mr. Alamgir Kabir for analytic assistance. We also thank the health care and administrative leadership of Gaibandha and Rangpur Districts, and ~120,000 participating women and their families within the JiVitA study area for their willing participation in this trial. We further acknowledge the helpful guidance of the project’s National Advisors on Reproductive Health (Dr. Halida Hanum Akhter) and Nutrition (Prof. Mamunar Rashid), and colleagues at the Johns Hopkins University Bloomberg School of Public Health (Alfred Sommer, Kerry Schulze, Lee Wu, and Joanne Katz). This trial was conducted by the Center for Human Nutrition, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University (JHU) under a Global Research Activity cooperative agreement between JHU and the Office of Health and Nutrition, US Agency for International Development (USAID), Washington DC (GHS-A-00-03-00019-00 and Micronutrients for Health Cooperative Agreement HRN-A-00-97-00015) and a grant from the Bill and Melinda Gates Foundation, Seattle, Washington (Global Control of Micronutrient Deficiency, Grant # 614). Additional direct or in-kind support was provided by Sight and Life (Basel, Switzerland), the Sight and Life Research Institute (Baltimore, MD), Nutrilite Health Institute (Nutrilite Division, Access Business Group, LLC, 5600 Beach Blvd, Buena Park, CA 90621), the Canadian International Development Agency (CIDA) and the National Integrated Population and Health Program (NIPHP) of the Ministry of Health and Family Welfare of the Government of the People’s Republic of Bangladesh.
PY - 2011/4/21
Y1 - 2011/4/21
N2 - Background: We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field.Methods: This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies.Results: The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity, maternal and infant micronutrient status, fetal and infant growth and prematurity, external birth defects and postnatal infant growth to 3 months of age.Conclusion: Aspects of study site selection and its "resonance" with national and rural qualities of Bangladesh, the trial's design, methods and allocation group comparability achieved by randomization, field procedures and innovative approaches to solving challenges in trial conduct are described and discussed. This trial is registered with http://Clinicaltrials.gov as protocol NCT00198822.
AB - Background: We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field.Methods: This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies.Results: The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity, maternal and infant micronutrient status, fetal and infant growth and prematurity, external birth defects and postnatal infant growth to 3 months of age.Conclusion: Aspects of study site selection and its "resonance" with national and rural qualities of Bangladesh, the trial's design, methods and allocation group comparability achieved by randomization, field procedures and innovative approaches to solving challenges in trial conduct are described and discussed. This trial is registered with http://Clinicaltrials.gov as protocol NCT00198822.
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U2 - 10.1186/1745-6215-12-102
DO - 10.1186/1745-6215-12-102
M3 - Article
C2 - 21510905
AN - SCOPUS:79954623924
SN - 1745-6215
VL - 12
JO - Trials
JF - Trials
M1 - 102
ER -