The prevention of malaria and anaemia in infants through iron supplementation and intermittent malaria treatment administered through the Expanded Programme on Immunization (EPI) Scheme (Tanzania)
| ISRCTN | ISRCTN88523834 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88523834 |
| Protocol serial number | 980483 |
| 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
- 21/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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 evaluate the impact of iron supplementation and the effectiveness of malaria intermittent treatment on the prevention of malaria and severe anaemia in infants. |
| Ethics approval(s) | Ethics approval received on the 26th June 1998. |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | All children receive oral daily iron syrup at a dosage of 2 mg/kg/day and will be randomly allocated to receive either intermittent malaria treatment (sulfadoxine-pyrimethamine) or a placebo at DPT2, DPT3 and measles vaccinations. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sulfadoxine-pyrimethamine |
| Primary outcome measure(s) | Incidence of clinical malaria and severe anaemia episodes in each group by 12 months of age. |
| Key secondary outcome measure(s) | 1. Incidence of clinical malaria and severe anaemia episodes up to 18 months of age 2. Incidence of clinical malaria and severe anaemia from 10 to 18 months of age 3. Prevalence of malaria parasitaemia at 12 and 18 months of age 4. Prevalence of severe and moderate anaemia at 12 and 18 months of age 5. Total number of admissions and outpatient attendances |
| Completion date | 26/06/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Female |
| Target sample size at registration | 680 |
| Key inclusion criteria | All children who attend the Mother and Child Health (MCH) clinic for their second Diphtheria, Pertussis, Tetanus (DPT) and polio immunisations and who are permanent residents in the study area of Ifakara town. |
| Key exclusion criteria | Infants who are not permanent residents in Ifakara. |
| Date of first enrolment | 26/06/1998 |
| Date of final enrolment | 26/06/2000 |
Locations
Countries of recruitment
- Switzerland
- Tanzania
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results at | 12/05/2001 | Yes | No | |
| Results article | follow-up results | 01/04/2005 | Yes | No |
