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

Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria; Anemia

Intervention: Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone) (Drug); iron (2 mg/kg/daily) (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Hospital Clinic of Barcelona

Official(s) and/or principal investigator(s):
Clara Menendez, MD, PhD, Principal Investigator, Affiliation: Centre for International Health, Hospital Clinic / Universitat Barcelona


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome:

Clinical Malaria

Severe Anemia (PCV < 25%)

Secondary outcome:

Clinical Malaria

Severe Anemia (PCV < 25%)

Outpatient visits

Hospital Admissions

Severe malaria

Detailed description: 411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprimâ„¢ (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.


Minimum age: N/A. Maximum age: 1 Day. Gender(s): Both.


Inclusion Criteria:

- Born in San Francis Designated District Hospital of Ifakara

Exclusion Criteria:

- Obvious severe congenital malformation such as: spina bifida, hydrocephalus or


- Twins

- Birth weight < 1,5 kg

- Clinical signs of cerebral asphyxia

- Clinical signs of neonatal or congenital infection

- Mother unreliable (deaf, mentally handicapped)

Locations and Contacts

Ifakara Centre, Ifakara, Tanzania
Additional Information

Starting date: February 1995
Last updated: July 5, 2007

Page last updated: August 20, 2015

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