The publication detail shows the title, authors (with indicators showing other profiled authors), information on the publishing organization, abstract and a link to the article in PubMed. This abstract is what is used to create the fingerprint of the publication. If any grants are referenced by the publication, they will be listed here as well.
A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods.
Alain B Labrique; Parul Christian; Rolf D W Klemm; Mahbubur Rashid; Abu Ahmed Shamim; Allan Massie; Kerry Schulze; Andre Hackman; Keith P West (Profiled Authors: Rolf Klemm; Kerry Schulze; Keith West; Allan Massie; Andre Hackman; Mahbubur Rashid; Alain Labrique; Parul Christian)
Center for Human Nutrition, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA. email@example.com
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.
This section shows information related to the publication - computed using the fingerprint of the publication - including related publications, related experts and related grants with fingerprints representing significant amounts of overlap between their fingerprint and this publication. The red dots indicate whether those experts or terms appear within the publication, thereby showing potential and actual connections.
Keith P West; Parul Christian; Alain B Labrique; Mahbubur Rashid; Abu Ahmed Shamim; Rolf D W Klemm; Allan B Massie; Sucheta Mehra; Kerry J Schulze; Hasmot Ali; et al.JAMA : the journal of the American Medical Association 2011;305(19):1986-95.
K P West; J Katz; S K Khatry; S C LeClerq; E K Pradhan; S R Shrestha; P B Connor; S M Dali; P Christian; R P Pokhrel; et al.BMJ (Clinical research ed.) 1999;318(7183):570-5.
Parul Christian; Rolf Klemm; Abu Ahmed Shamim; Hasmot Ali; Mahbubur Rashid; Saijuddin Shaikh; Lee Wu; Sucheta Mehra; Alain Labrique; Joanne Katz; et al.The American journal of clinical nutrition 2013;97(1):188-94.
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