Intermittent malaria treatment and iron supplementation for the control of malaria and anaemia in infants in the Forest Belt of rural Ghana: a double-blind randomised controlled trial

ISRCTN	ISRCTN85737357
DOI	https://doi.org/10.1186/ISRCTN85737357
Protocol serial number	980643
Sponsor	UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Funder	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)

Submission date: 01/02/2006
Registration date: 01/02/2006
Last edited: 02/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Melba Gomes
Scientific

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 (0)22 791 3813
Email	gomesm@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To establish whether preventive treatment or iron supplementation given at EPI prevented either severe anaemia or malaria.
Ethics approval(s)	Ethics approval received on the 17th June 1999.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	17/06/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	1800
Key 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.
Key exclusion criteria	Infants who are not permanent residents of Afigya-Sekyere District, Ashanti Region.
Date of first enrolment	17/06/1999
Date of final enrolment	17/06/2001

Locations

Countries of recruitment

Ghana
Switzerland

Study participating centre

20, Avenue Appia

Geneva-27
CH 1211
Switzerland

Results and Publications

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