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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: Study protocol for a randomized controlled trial
Trials, Volume 13, Article 22, Year 2012
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Description
Background: Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo.Methods/Design: The trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrolment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation.Discussion: The three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies.Trial Registration: Ghana: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12610000582055; India: CLINICALTRIALS.GOV - NCT01138449; Tanzania: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12610000636055. © 2012 NEOVITA Study Author Group et al; licensee BioMed Central Ltd.
Authors & Co-Authors
Bahl, Rajiv
Unknown Affiliation
Bhandari, Nita R.
Unknown Affiliation
Dube, Brinda
Unknown Affiliation
Edmond, Karen Margaret
Unknown Affiliation
Fawzi, Wafaie W.
Unknown Affiliation
Fontaine, Olivier
Unknown Affiliation
Kaur, Jasmine
Unknown Affiliation
Kirkwood, Betty R.
Unknown Affiliation
Martines, José Carlos
Unknown Affiliation
Masanja, Honorati M.
Unknown Affiliation
Mazumder, Sarmila
Unknown Affiliation
Msham, Salum
Unknown Affiliation
Newton, Sam Kofi Tekyi
Unknown Affiliation
Oleary, Maureen
Unknown Affiliation
Ruben, Julia
Unknown Affiliation
Shannon, Caitlin S.
Unknown Affiliation
Smith, Emily Rose
Unknown Affiliation
Taneja, Sunita
Unknown Affiliation
Yoshida, Sachiyo
Unknown Affiliation
Statistics
Citations: 42
Authors: 19
Affiliations: 7
Identifiers
Doi:
10.1186/1745-6215-13-22
e-ISSN:
17456215
Research Areas
Health System And Policy
Maternal And Child Health
Study Design
Randomised Control Trial
Study Approach
Quantitative
Study Locations
Ghana
Tanzania