Efficacy of zinc or iron supplementation during first three years of life in preventing mortality in Zanzibar (Tanzania)

ISRCTN	ISRCTN59549825
DOI	https://doi.org/10.1186/ISRCTN59549825
Protocol serial number	WHO/CAH ID 00003
Sponsor	The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)
Funder	The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Olivier Fontaine
Scientific

World Health Organization
20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Email	fontaineo@who.int

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To assess the effect of iron and folic acid supplementation on severe morbidity and mortality.
Ethics approval(s)	Ethics approval received from the World Health Organization (WHO) ethical committee (Sub Committee on Research Involving Human Subjects [SCRIHS]) in the year 2000.
Health condition(s) or problem(s) studied	Severe morbidity and mortality
Intervention	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).
Intervention type	Supplement
Primary outcome measure(s)	Serious adverse events (a composite of hospital admissions and all-cause deaths)
Key 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
Completion date	19/08/2003

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Month
Upper age limit	35 Months
Sex	All
Target sample size at registration	24076
Key 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
Key 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
Date of first enrolment	01/01/2003
Date of final enrolment	19/08/2003

World Health Organization

Geneva-27
CH 1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	14/01/2006	Yes	No
Results article	results	17/03/2007	Yes	No
Results article	results	01/09/2013	Yes	No