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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)
Agencia Española de Cooperación Internacional
World Health Organization
Information provided by:
Hospital Clinic of Barcelona Identifier:
First received: July 5, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
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
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-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:

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.

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)
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Please refer to this study by its identifier: 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

Publications: Identifier: NCT00497471     History of Changes
Other Study ID Numbers: IronMal
Study First Received: July 5, 2007
Last Updated: July 5, 2007

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

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Hematologic 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 processed this record on May 25, 2017