TY - JOUR
T1 - Effect of zinc supplementation on mortality in children aged 1-48 months
T2 - a community-based randomised placebo-controlled trial
AU - Sazawal, Sunil
AU - Black, Robert E.
AU - Ramsan, Mahdi
AU - Chwaya, Hababu M.
AU - Dutta, Arup
AU - Dhingra, Usha
AU - Stoltzfus, Rebecca J.
AU - Othman, Mashavi K.
AU - Kabole, Fatma M.
N1 - Funding Information:
This study was supported by a grant from WHO, Department of Child and Adolescent Health and Development with funds from United Nations Foundation, from the Family Health and Child Survival and Global Research Activity, Cooperative Agreements between Johns Hopkins Department of International Health and the United States Agency for International Development, and from the Bill & Melinda Gates Foundation through its support for micronutrient research at the Johns Hopkins Bloomberg School of Public Health. We thank the participating children, their parents, and the study team, including field workers, supervisors, physicians, data managers and other support staff for their contributions and support; the Ministry of Health and Social Welfare of the Government of Zanzibar, Tanzania for guidance and infrastructure support at every stage of the study; the Public Health Laboratory (Ivo de Carnari) as collaborating institution for contributions to management, community relations and other support. We also thank Olivier Fontaine for contributions on behalf of WHO in study design, development, supply of supplements, active monitoring, coordination of the DSMB, and interpretation of results. We would also like to thank the Data and Safety Monitoring Board members Michael Hambidge, William Blackwelder, and Zul Premji.
PY - 2007/3/17
Y1 - 2007/3/17
N2 - Background: Studies from Asia have suggested that zinc supplementation can reduce morbidity and mortality in children, but evidence from malarious populations in Africa has been inconsistent. Our aim was to assess the effects of zinc supplementation on overall mortality in children in Pemba, Zanzibar. Methods: We enrolled 42 546 children aged 1-36 months, contributing a total of 56 507 child-years in a randomised, double-blind, placebo-controlled trial in Pemba, Zanzibar. Randomisation was by household. 21 274 children received daily supplementation with zinc 10 mg (5 mg in children younger than 12 months) for mean 484·7 days (SD 306·6). 21 272 received placebo. The primary endpoint was overall mortality, and analysis was by intention to treat. This study is registered as an International Standard Randomised Clinical Trial, number ISRCTN59549825. Findings: Overall, there was a non-significant 7% (95% CI -6% to 19%; p=0·29) reduction in the relative risk of all-cause mortality associated with zinc supplementation. Interpretation: We believe that a meta-analysis of all studies of mortality and morbidity, will help to make evidence-based recommendations for the role of zinc supplementation in public health policy to improve mortality, morbidity, growth, and development in young children.
AB - Background: Studies from Asia have suggested that zinc supplementation can reduce morbidity and mortality in children, but evidence from malarious populations in Africa has been inconsistent. Our aim was to assess the effects of zinc supplementation on overall mortality in children in Pemba, Zanzibar. Methods: We enrolled 42 546 children aged 1-36 months, contributing a total of 56 507 child-years in a randomised, double-blind, placebo-controlled trial in Pemba, Zanzibar. Randomisation was by household. 21 274 children received daily supplementation with zinc 10 mg (5 mg in children younger than 12 months) for mean 484·7 days (SD 306·6). 21 272 received placebo. The primary endpoint was overall mortality, and analysis was by intention to treat. This study is registered as an International Standard Randomised Clinical Trial, number ISRCTN59549825. Findings: Overall, there was a non-significant 7% (95% CI -6% to 19%; p=0·29) reduction in the relative risk of all-cause mortality associated with zinc supplementation. Interpretation: We believe that a meta-analysis of all studies of mortality and morbidity, will help to make evidence-based recommendations for the role of zinc supplementation in public health policy to improve mortality, morbidity, growth, and development in young children.
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U2 - 10.1016/S0140-6736(07)60452-8
DO - 10.1016/S0140-6736(07)60452-8
M3 - Article
C2 - 17368154
AN - SCOPUS:33947167237
SN - 0140-6736
VL - 369
SP - 927
EP - 934
JO - Lancet
JF - Lancet
IS - 9565
ER -