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

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ClinicalTrials.gov Identifier: NCT00497471
Recruitment Status : Terminated (Follow-up end in 1999)
First Posted : July 6, 2007
Last Update Posted : July 6, 2007
Information provided by:

Study Description
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

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 832 participants
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
Study Start Date : February 1995
Study Completion Date : July 1999

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Clinical Malaria [ Time Frame: During first year of life ]
  2. Severe Anemia (PCV < 25%) [ Time Frame: During first year of life ]

Secondary Outcome Measures :
  1. Clinical Malaria [ Time Frame: After first year of life ]
  2. Severe Anemia (PCV < 25%) [ Time Frame: After first year of life ]
  3. Outpatient visits
  4. Hospital Admissions
  5. Severe malaria

Eligibility Criteria

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

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

Ifakara Centre
Ifakara, Tanzania
Sponsors and Collaborators
Hospital Clinic of Barcelona
Agencia Española de Cooperación Internacional
World Health Organization
Principal Investigator: Clara Menendez, MD, PhD Centre for International Health, Hospital Clinic / Universitat Barcelona
More Information

ClinicalTrials.gov Identifier: NCT00497471     History of Changes
Other Study ID Numbers: IronMal
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: July 2007

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

Additional relevant MeSH terms:
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents