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

This study has been terminated.

Sponsors and Collaborators:	Hospital Clinic of Barcelona Agencia Española de Cooperación Internacional World Health Organization
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00497471

Purpose

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	Intervention
Malaria Anemia	Drug: Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone) Drug: iron (2 mg/kg/daily)

MedlinePlus related topics: Anemia Malaria

Drug Information available for: Pyrimethamine Dapsone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	832
Study Start Date:	February 1995
Study Completion Date:	July 1999

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.

Eligibility

Ages Eligible for Study:	up to 1 Day
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497471

Locations

Tanzania
Ifakara Centre
Ifakara, Tanzania

Sponsors and Collaborators

Hospital Clinic of Barcelona

Agencia Española de Cooperación Internacional

World Health Organization

Investigators

Principal Investigator:

Clara Menendez, MD, PhD

Centre for International Health, Hospital Clinic / Universitat Barcelona

More Information

Publications of Results:

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.

Study ID Numbers:	IronMal
Study First Received:	July 5, 2007
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00497471
Health Authority:	Tanzania: National Institute for Medical Research

Keywords provided by Hospital Clinic of Barcelona:

Plasmodium Falciparum
Antimlarial chemoprophylaxis
Iron supplementation
Tanzania

Study placed in the following topic categories:

Folic Acid
Pyrimethamine
Protozoan Infections
Hematologic Diseases
Anemia

Dapsone
Parasitic Diseases
Malaria
Iron

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action

Coccidiosis
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009