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

Hospital Clinic of Barcelona832 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

832

Conditions

Malaria Anemia

Interventions

Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)DRUG

iron (2 mg/kg/daily)DRUG

Eligibility

Sex: ALLMin age: 1 DayMax age: 1 DayHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Ifakara Centre

Ifakara, Tanzania

Outcomes

Primary Outcomes

Clinical Malaria

Time frame: During first year of life

Severe Anemia (PCV < 25%)

Time frame: During first year of life

Secondary Outcomes

Clinical Malaria

Time frame: After first year of life

Severe Anemia (PCV < 25%)

Time frame: After first year of life

Outpatient visits

Hospital Admissions

Severe malaria

Data from ClinicalTrials.gov

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