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
Scientific
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 3813 |
|---|---|
| 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
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 |
