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

Hospital Clinic of Barcelona

Status

Terminated

Conditions

Anemia

Malaria

Treatments

Drug: iron (2 mg/kg/daily)

Drug: Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)

Study type

Interventional

Funder types

Other

Identifiers

NCT00497471

IronMal

Details and patient eligibility

About

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

Full 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.

Enrollment

832 patients

Sex

All

Ages

1 to 1 day old

Volunteers

Accepts Healthy Volunteers

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)