Condition category
Signs and Symptoms
Date applied
27/07/2004
Date assigned
28/07/2004
Last edited
28/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olivier Fontaine

ORCID ID

Contact details

World Health Organization
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
fontaineo@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/CAH ID 00003

Study information

Scientific title

Acronym

Study hypothesis

To assess the effect of iron and folic acid supplementation on severe morbidity and mortality.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Zinc, vitamin A supplementation

Primary outcome measures

Serious adverse events (a composite of hospital admissions and all-cause deaths)

Secondary outcome measures

1. Death during follow-up or within 30 days of stopping supplementation
2. Hospital admission to any of the five public hospitals in Pemba

Overall trial start date

01/01/2003

Overall trial end date

19/08/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

24076 children (at time of final enrolment)

Participant 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

Recruitment start date

01/01/2003

Recruitment end date

19/08/2003

Locations

Countries of recruitment

Tanzania

Trial participating centre

World Health Organization
Geneva-27
CH 1211
Switzerland

Sponsor information

Organisation

The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)

Sponsor details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Sazawal S, Black RE, Ramsan M, Chwaya HM, Stoltzfus RJ, Dutta A, Dhingra U, Kabole I, Deb S, Othman MK, Kabole FM, Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial., Lancet, 2006, 367, 9505, 133-143, doi: 10.1016/S0140-6736(06)67962-2.

  2. Results

    Sazawal S, Black RE, Ramsan M, Chwaya HM, Dutta A, Dhingra U, Stoltzfus RJ, Othman MK, Kabole FM, Effect of zinc supplementation on mortality in children aged 1-48 months: a community-based randomised placebo-controlled trial., Lancet, 2007, 369, 9565, 927-934, doi: 10.1016/S0140-6736(07)60452-8.

  3. Results

    Olney DK, Kariger PK, Stoltzfus RJ, Khalfan SS, Ali NS, Tielsch JM, Sazawal S, Black R, Allen LH, Pollitt E, Developmental effects of micronutrient supplementation and malaria in Zanzibari children., Early Hum. Dev., 2013, 89, 9, 667-674, doi: 10.1016/j.earlhumdev.2013.04.013.

Additional files

Editorial Notes