RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants
Not Applicable
Terminated
- Conditions
- AnemiaMalaria
- Registration Number
- NCT00497471
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 832
Inclusion Criteria
- Born in San Francis Designated District Hospital of Ifakara
Exclusion Criteria
- Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
- Twins
- Birth weight < 1,5 kg
- Clinical signs of cerebral asphyxia
- Clinical signs of neonatal or congenital infection
- Mother unreliable (deaf, mentally handicapped)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Severe Anemia (PCV < 25%) During first year of life Clinical Malaria During first year of life
- Secondary Outcome Measures
Name Time Method Outpatient visits Severe Anemia (PCV < 25%) After first year of life Severe malaria Hospital Admissions Clinical Malaria After first year of life
Trial Locations
- Locations (1)
Ifakara Centre
🇹🇿Ifakara, Tanzania