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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00497471

Enrollment

832

Registered

2007-07-06

Start date

1995-02-28

Completion date

1999-07-31

Last updated

2007-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Malaria

Keywords

Plasmodium Falciparum, Antimlarial chemoprophylaxis, Iron supplementation, Tanzania

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

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.

Interventions

DRUGDeltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)

DRUGiron (2 mg/kg/daily)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

1 Days to 1 Days

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)

Design outcomes

Primary

Measure	Time frame
Clinical Malaria	During first year of life
Severe Anemia (PCV < 25%)	During first year of life

Secondary

Measure	Time frame
Clinical Malaria	After first year of life
Severe Anemia (PCV < 25%)	After first year of life
Outpatient visits	—
Hospital Admissions	—
Severe malaria	—

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026