NCT00301054

Brief Summary

A study that seeks to establish an effective way of preventing anaemia in children at the community level using two known interventions - Iron supplementation and or antimalarial. Children recruited into the study will be assigned to four groups. Those receiving Placebo and Iron, those receiving Placebo and Antimalarial, those receiving Placebo and Antimalarial and those receiving double placebo. The children will be followed up over a period of nine months and their haemoglobin concentration, malaria parasites in their blood and their weight and height will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
872

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 29, 2006

Status Verified

July 1, 2005

First QC Date

March 9, 2006

Last Update Submit

May 26, 2006

Conditions

Keywords

AnaemiaMalariaRural Area in Ghana

Outcome Measures

Primary Outcomes (1)

  • Haemoglobin concentration, Blood Film for malaria parasitaemia, weight/height ratio

Secondary Outcomes (1)

  • Incidence of vaccine preventable diseases like measles whooping cough(pertussis)

Interventions

Eligibility Criteria

Age6 Months - 30 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children living in Berekum District who are between 6months- 30months

You may not qualify if:

  • All Children living in Berekum District between 6months- 30months who are G6PD Deficient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Health Directorate

Berekum, Brong- Ahafo, Ghana

Location

Related Publications (2)

  • Alonzo Gonzalez M, Menendez C, Font F, Kahigwa E, Kimario J, Mshinda H, Tanner M, Bosch-Capblanch X, Alonso PL. Cost-effectiveness of iron supplementation and malaria chemoprophylaxis in the prevention of anaemia and malaria among Tanzanian infants. Bull World Health Organ. 2000;78(1):97-107.

    PMID: 10686744BACKGROUND
  • Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.

    PMID: 11377597BACKGROUND

MeSH Terms

Conditions

AnemiaMalaria

Interventions

ferrous sulfatefanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • ANTHONY A OFOSU, MBChB, MPH

    GHANA HEALTH SERVICE BEREKUM DISTRICT

    PRINCIPAL INVESTIGATOR
  • DONNA M DENNO, MD, PAEDS

    UNIVERSITY OF WASHINGTON MEDICAL CENTER, SEATTLE, USA

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 9, 2006

First Posted

March 10, 2006

Study Start

June 1, 2005

Study Completion

April 1, 2006

Last Updated

May 29, 2006

Record last verified: 2005-07

Locations