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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

July 5, 2007
July 5, 2007
February 1995
Not Provided
  • Clinical Malaria [ Time Frame: During first year of life ]
  • Severe Anemia (PCV < 25%) [ Time Frame: During first year of life ]
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants
The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Malaria
  • Anemia
  • Drug: Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)
  • Drug: iron (2 mg/kg/daily)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
832
July 1999
Not Provided

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)
Both
up to 1 Day
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00497471
IronMal
Yes
Not Provided
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
Hospital Clinic of Barcelona
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP