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

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Terminated

CT.gov ID

NCT00497471

Collaborator

Agencia Española de Cooperación Internacional (Other), World Health Organization (Other)

832

Enrollment

Location

52.9

Duration (Months)

15.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Malaria Anemia	Drug: Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone) Drug: iron (2 mg/kg/daily)	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

832 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 1995

Actual Study Completion Date :

Jul 1, 1999

Outcome Measures

Primary Outcome Measures

Clinical Malaria [During first year of life]
Severe Anemia (PCV < 25%) [During first year of life]

Secondary Outcome Measures

Clinical Malaria [After first year of life]
Severe Anemia (PCV < 25%) [After first year of life]
Outpatient visits []
Hospital Admissions []
Severe malaria []

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 1 Day

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)