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
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
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 MalariaSevere Anemia (PCV < 25%)
Secondary outcome: Clinical MalariaSevere 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.
Eligibility
Minimum age: N/A.
Maximum age: 1 Day.
Gender(s): Both.
Criteria:
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 and Contacts
Ifakara Centre, Ifakara, Tanzania
Additional Information
Starting date: February 1995
Last updated: July 5, 2007
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