NCT00497471

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
832

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 1995

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1995

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1999

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
Last Updated

July 6, 2007

Status Verified

July 1, 2007

First QC Date

July 5, 2007

Last Update Submit

July 5, 2007

Conditions

MalariaAnemia

Keywords

Plasmodium FalciparumAntimlarial chemoprophylaxisIron supplementationTanzania

Outcome Measures

Primary Outcomes (2)

  • Clinical Malaria

    During first year of life

  • Severe Anemia (PCV < 25%)

    During first year of life

Secondary Outcomes (5)

  • Clinical Malaria

    After first year of life

  • Severe Anemia (PCV < 25%)

    After first year of life

  • Outpatient visits

  • Hospital Admissions

  • Severe malaria

Interventions

Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)DRUG
iron (2 mg/kg/daily)DRUG

Eligibility Criteria

Age1 Day - 1 Day
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born in San Francis Designated District Hospital of Ifakara

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifakara Centre

Ifakara, Tanzania

Location

Related Publications (1)

  • 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.

    PMID: 9310602RESULT

MeSH Terms

Conditions

MalariaAnemiaMalaria, Falciparum

Interventions

PyrimethamineDapsoneIron

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonesSulfur CompoundsOrganic ChemicalsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Clara Menendez, MD, PhD

    Centre for International Health, Hospital Clinic / Universitat Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

February 1, 1995

Study Completion

July 1, 1999

Last Updated

July 6, 2007

Record last verified: 2007-07

Locations

TA(1)