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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:
ClinicalTrials.gov Identifier:
NCT00497471
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Agencia Española de Cooperación Internacional
World Health Organization
Information provided by:
Hospital Clinic of Barcelona
  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
Intervention Model: Factorial Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 5, 2007
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
Last Verified: July 2007

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
Iron
Pyrimethamine
Dapsone
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents