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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NCT01231880 |
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Date of registration:
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29/10/2010 |
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Primary sponsor: |
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Public title:
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School Based Malaria Control in Ugandan Schoolchildren
SBMC |
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Scientific title:
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School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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740 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01231880 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Joaniter I Nankabirwa, MSc CEB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Makerere University Kampala |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 6 - 14 years
- Pupils enrolled at participating school
- Willingness of the parent/guardian to provide consent
- Provision of assent by pupil (those above 8 years)
Exclusion Criteria:
- Known allergy or history of adverse reaction to study medications
- Intention of changing of schools during the follow-up period
- History (obtained from the parent/guardian) of any known serious chronic disease
requiring frequent medical care
Age minimum:
6 Years
Age maximum:
14 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)
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Drug: Monthly IPT using DP
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Drug: Placebo given every month
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Primary Outcome(s)
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Cognitive function tests
[Time Frame: 1 year]
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Risk of Clinical Malaria
[Time Frame: 1 year]
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Secondary Outcome(s)
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Prevalence of anemia
[Time Frame: 1 year]
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Risk of adverse events
[Time Frame: 1 year]
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Risk of hospital admissions
[Time Frame: 1 year]
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Risk of parasitemia
[Time Frame: 1 year]
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School performance
[Time Frame: 1 year]
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Secondary ID(s)
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MCDC-SBMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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