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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85737357

Enrollment

1800

Registered

2006-02-01

Start date

1999-06-17

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Malaria

Interventions

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 sulphadox

Eligibility

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

Ghana

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026