RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants
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ClinicalTrials.gov Identifier: NCT00497471
(Follow-up end in 1999)
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
Condition or disease
Drug: Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)Drug: iron (2 mg/kg/daily)
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.
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Ages Eligible for Study:
up to 1 Day (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Born in San Francis Designated District Hospital of Ifakara
Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
Birth weight < 1,5 kg
Clinical signs of cerebral asphyxia
Clinical signs of neonatal or congenital infection