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RCT 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
Hospital Clinic of Barcelona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Plasmodium Falciparum, Antimlarial chemoprophylaxis, Iron supplementation, Tanzania

Eligibility Criteria

1 Day - 1 Day (Child)All SexesAccepts Healthy Volunteers

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

First Posted
July 5, 2007
Last Updated
July 5, 2007
Sponsor
Hospital Clinic of Barcelona
Collaborators
Agencia Española de Cooperación Internacional, World Health Organization
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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
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RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants

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