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NCT00497471 Clinical Trial

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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00497471
Other study ID # IronMal
Secondary ID
Status Terminated
Phase N/A
First received July 5, 2007
Last updated July 5, 2007
Start date February 1995
Est. completion date July 1999

Study information
Verified date July 2007
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Tanzania: National Institute for Medical Research
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 832
Est. completion date July 1999
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 1 Day
Eligibility 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)

Study Design

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

Related Conditions & MeSH terms

Intervention

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

• iron (2 mg/kg/daily)

Locations
Country Name City State
Tanzania Ifakara Centre Ifakara

Sponsors (3)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona Agencia Española de Cooperación Internacional, World Health Organization

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemopro — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Malaria During first year of life
Primary Severe Anemia (PCV < 25%) During first year of life
Secondary Clinical Malaria After first year of life
Secondary Severe Anemia (PCV < 25%) After first year of life
Secondary Outpatient visits
Secondary Hospital Admissions
Secondary Severe malaria
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