NCT00497471

RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants

The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 832 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 1 Day – 1 Day
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission

Detailed description

411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.

Conditions

• Malaria
• Anemia

Interventions

Type	Name	Description
DRUG	Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)
DRUG	iron (2 mg/kg/daily)

Timeline

• Start date: 1995-02-01
• Completion: 1999-07-01
• First posted: 2007-07-06
• Last updated: 2007-07-06

Locations

1 site across 1 country: Tanzania