Condition category
Infections and Infestations
Date applied
01/02/2006
Date assigned
01/02/2006
Last edited
02/10/2007
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 Melba Gomes

ORCID ID

Contact details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3813
gomesm@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

980643

Study information

Scientific title

Acronym

Study hypothesis

To establish whether preventive treatment or iron supplementation given at EPI prevented either severe anaemia or malaria.

Ethics approval

Ethics approval received on the 17th June 1999.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malaria

Intervention

Double blind placebo controlled trial. One of the following treatments given to children at the time of DPT2, DPT3 and measles vaccination:
1. Iron supplementation and placebo
2. Placebo and sulphadoxine pyrimethamine
3. Iron supplementation and sulphadoxine pyrimethamine

Intervention type

Supplement

Phase

Not Specified

Drug names

Iron supplementation, sulphadoxine pyrimethamine

Primary outcome measures

1. To assess the effectiveness of intermittent malaria treatment (1.25 mg pyrimethamine plus 25 mg sulfadoxine/kg) given at 10 weeks, 14 weeks and 9 months through the EPI programme in the control of malaria and severe anaemia in infancy
2. To determine the effect of intermittent malaria treatment in infancy on the risk of malaria and anaemia in childhood after completion of trial
3. To evaluate the effect of daily iron supplementation (2 mg/kg) given from 10 weeks to 12 months through the EPI programme on the control of malaria and severe anaemia
4. To assess the socio-cultural factors influencing acceptability of treatment modalities
5. To evaluate the cost effectiveness of interventions

Secondary outcome measures

No secondary outcome measures

Overall trial start date

17/06/1999

Overall trial end date

17/06/2001

Reason abandoned

Eligibility

Participant inclusion criteria

All infants aged at least 10 weeks attending a Mother and Child Health (MCH) Clinic or Child Welfare Clinic (CWC) in the Afigya-Sekyere District, Ashanti Region and are permanent residents in the district. Their mothers or main carers should have given informed consent to participate in the trial.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

450 infants/arm - 1800 infants in total randomised

Participant exclusion criteria

Infants who are not permanent residents of Afigya-Sekyere District, Ashanti Region.

Recruitment start date

17/06/1999

Recruitment end date

17/06/2001

Locations

Countries of recruitment

Ghana

Trial participating centre

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

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

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

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

Publication citations

Additional files

Editorial Notes