Study on Preventing Anemia in Children in Ghana

This study has been completed.
Sponsor:
Collaborator:
Netherlands Overseas Agency
Information provided by:
Ghana Health Services
ClinicalTrials.gov Identifier:
NCT00301054
First received: March 9, 2006
Last updated: May 26, 2006
Last verified: July 2005
  Purpose

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.


Condition Intervention
Anaemia in Children
Drug: Ferrous sulphate
Drug: Sulphadoxine-Pyrimethamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Preventing Anemia in Children (6months-30months) in a Malaria Endemic Rural Area in Ghana - A Randomized Double Blind Study

Resource links provided by NLM:


Further study details as provided by Ghana Health Services:

Primary Outcome Measures:
  • Haemoglobin concentration, Blood Film for malaria parasitaemia, weight/height ratio

Secondary Outcome Measures:
  • Incidence of vaccine preventable diseases like measles whooping cough(pertussis)

Estimated Enrollment: 872
Study Start Date: June 2005
Estimated Study Completion Date: April 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • All Children living in Berekum District between 6months- 30months who are G6PD Deficient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301054

Locations
Ghana
District Health Directorate
Berekum, Brong- Ahafo, Ghana
Sponsors and Collaborators
Ghana Health Services
Netherlands Overseas Agency
Investigators
Principal Investigator: ANTHONY A OFOSU, MBChB, MPH GHANA HEALTH SERVICE BEREKUM DISTRICT
Study Director: DONNA M DENNO, MD, PAEDS UNIVERSITY OF WASHINGTON MEDICAL CENTER, SEATTLE, USA
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00301054     History of Changes
Other Study ID Numbers: 2003/GD/23
Study First Received: March 9, 2006
Last Updated: May 26, 2006
Health Authority: Ghana: Ministry of Health

Keywords provided by Ghana Health Services:
Anaemia
Malaria
Rural Area in Ghana

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 16, 2014