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Efficacy of zinc or iron supplementation during first three years of life in preventing mortality in Zanzibar (Tanzania)
ISRCTN ISRCTN59549825
DOI 10.1186/ISRCTN59549825
ClinicalTrials.gov identifier
EudraCT number
Public title Efficacy of zinc or iron supplementation during first three years of life in preventing mortality in Zanzibar (Tanzania)
Scientific title
Acronym N/A
Serial number at source WHO/CAH ID 00003
Study hypothesis To assess the effect of iron and folic acid supplementation on severe morbidity and mortality.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the World Health Organization (WHO) ethical committee (Sub Committee on Research Involving Human Subjects [SCRIHS]) in the year 2000.
Study design Randomised controlled trial
Countries of recruitment Tanzania
Disease/condition/study domain Severe morbidity and mortality
Participants - inclusion criteria 1. Children aged 1 to 35 months
2. Resident of the Pemba Island and likely to remain in the area during the study period
3. Parents consenting to participate in the trial
Participants - exclusion criteria 1. Children unable to swallow
2. Children hospitalised or receiving therapeutic multivitamins supplements are only recruited once discharged from hospital or supplement therapy is stopped
3. Children with clinically severe malnutrition will be re-evaluated after completion of the rehabilitation
Anticipated start date 01/01/2003
Anticipated end date 19/08/2003
Status of trial Completed
Patient information material
Target number of participants 24076 children (at time of final enrolment)
Interventions 5 mg zinc or placebo/day for infants less than 6 months and 10 mg/day for infants older than 6 months. All children will receive daily vitamin A supplement (one tablet for infants greater than 6 months and half tablet for infants less than 6 months).
Primary outcome measure(s) Serious adverse events (a composite of hospital admissions and all-cause deaths)
Secondary outcome measure(s) 1. Death during follow-up or within 30 days of stopping supplementation
2. Hospital admission to any of the five public hospitals in Pemba
Sources of funding The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)
Trial website
Publications 1. 2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16413877
2. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17368154
3. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23725789
Contact name Dr  Olivier  Fontaine
  Address World Health Organization
20, Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH 1211
  Country Switzerland
  Email fontaineo@who.int
Sponsor The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)
  Address 20, Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH 1211
  Country Switzerland
  Sponsor website: http://www.who.int
Date applied 27/07/2004
Last edited 28/02/2014
Date ISRCTN assigned 28/07/2004
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