Back to resultsRCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants
Primary Purpose
Malaria, Anemia
Status
Terminated
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)
iron (2 mg/kg/daily)
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Plasmodium Falciparum, Antimlarial chemoprophylaxis, Iron supplementation, Tanzania
Eligibility 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)
Sites / Locations
- Ifakara Centre
Outcomes
Primary Outcome Measures
Clinical Malaria
Severe Anemia (PCV < 25%)
Secondary Outcome Measures
Clinical Malaria
Severe Anemia (PCV < 25%)
Outpatient visits
Hospital Admissions
Severe malaria
Full Information
NCT ID
NCT00497471
First Posted
July 5, 2007
Last Updated
July 5, 2007
Sponsor
Hospital Clinic of Barcelona
Collaborators
Agencia Española de Cooperación Internacional, World Health Organization
1. Study Identification
Unique Protocol Identification Number
NCT00497471
Brief Title
RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants
Official Title
The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Why Stopped
Follow-up end in 1999
Study Start Date
February 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Agencia Española de Cooperación Internacional, World Health Organization
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Anemia
Keywords
Plasmodium Falciparum, Antimlarial chemoprophylaxis, Iron supplementation, Tanzania
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
832 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)
Intervention Type
Drug
Intervention Name(s)
iron (2 mg/kg/daily)
Primary Outcome Measure Information:
Title
Clinical Malaria
Time Frame
During first year of life
Title
Severe Anemia (PCV < 25%)
Time Frame
During first year of life
Secondary Outcome Measure Information:
Title
Clinical Malaria
Time Frame
After first year of life
Title
Severe Anemia (PCV < 25%)
Time Frame
After first year of life
Title
Outpatient visits
Title
Hospital Admissions
Title
Severe malaria
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Menendez, MD, PhD
Organizational Affiliation
Centre for International Health, Hospital Clinic / Universitat Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ifakara Centre
City
Ifakara
Country
Tanzania
12. IPD Sharing Statement
Citations:
PubMed Identifier
9310602
Citation
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. doi: 10.1016/S0140-6736(97)04229-3.
Results Reference
result
Learn more about this trial
RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants
We'll reach out to this number within 24 hrs