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

This study has been terminated.
(Follow-up end in 1999)
Sponsor:
Collaborators:
Agencia Española de Cooperación Internacional
World Health Organization
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00497471
First received: July 5, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron Malaria
U.S. FDA Resources

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:

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

Keywords provided by Hospital Clinic of Barcelona:
Plasmodium Falciparum
Antimlarial chemoprophylaxis
Iron supplementation
Tanzania

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Iron
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013