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Study on Preventing Anemia in Children in Ghana

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ClinicalTrials.gov Identifier: NCT00301054
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : May 29, 2006
Sponsor:
Collaborator:
Netherlands Overseas Agency
Information provided by:
Ghana Health Services

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.

Condition or disease Intervention/treatment Phase
Anaemia in Children Drug: Ferrous sulphate Drug: Sulphadoxine-Pyrimethamine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 872 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Preventing Anemia in Children (6months-30months) in a Malaria Endemic Rural Area in Ghana - A Randomized Double Blind Study
Study Start Date : June 2005
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Malaria
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00301054     History of Changes
Other Study ID Numbers: 2003/GD/23
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: May 29, 2006
Last Verified: July 2005

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

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