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Main
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Note: This record shows only 22 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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16 December 2017 |
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Main ID: |
NCT03035305 |
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Date of registration:
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17/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali
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Scientific title:
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Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Kolokani Circle, Koulikoro Region, Mali, August-November 2016: Interventional Matched-pair Clustered Cohort |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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36717 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03035305 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Mali
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Contacts
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Name:
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Susan Shepherd, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Alliance for International Medical Action (ALIMA) |
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Name:
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Renaud Becquet, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inserm U1219 Bordeaux Population Health Center, University of Bordeaux |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Being between 6 and 59 months old
- Resident in the study area
- Signed informed consent of the mother or the child's guardian
Exclusion Criteria:
- Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine
Age minimum:
6 Months
Age maximum:
59 Months
Gender:
All
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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: Seasonal malaria chemoprevention
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Dietary Supplement: Lipid-based Nutrient Supplement (LNS)
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Primary Outcome(s)
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Confirmed malaria case
[Time Frame: From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks]
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Secondary Outcome(s)
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Fever case
[Time Frame: From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks]
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Global acute malnutrition case
[Time Frame: From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks]
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Severe acute malnutrition case
[Time Frame: From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks]
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Medical referral case
[Time Frame: From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks]
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Moderate acute malnutrition case
[Time Frame: From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks]
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Secondary ID(s)
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SMC LNS Mali
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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