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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

832 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-02-28

Study Completion Date

1999-07-31

Brief Summary

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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

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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.

Conditions

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Malaria Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)

Intervention Type DRUG

iron (2 mg/kg/daily)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Clara Menendez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for International Health, Hospital Clinic / Universitat Barcelona

Locations

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Ifakara Centre

Ifakara, , Tanzania

Site Status

Countries

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Tanzania

References

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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 chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.

Reference Type RESULT

PMID: 9310602 (View on PubMed)

Other Identifiers

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IronMal

Identifier Type: -

Identifier Source: org_study_id