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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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28 June 2021 |
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Main ID: |
NCT04698070 |
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Date of registration:
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19/12/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Niger (OptIMA Niger)
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Scientific title:
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Evaluation of Two Optimizing and Simplifying Strategies on Acute Malnutrition Treatment in Children Aged 6 to 59 Months in Mirriah District, Zinder, Niger |
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Date of first enrolment:
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March 22, 2021 |
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Target sample size:
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2466 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04698070 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. 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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Niger
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Contacts
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Name:
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Maguy Daures, MSc |
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Address:
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Telephone:
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+33557571539 |
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Email:
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maguy.daures@coral.alima.ngo |
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Affiliation:
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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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Alliance for International Medical Action |
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Name:
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Renaud Becquet, MPH,PhD,HDR |
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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 |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Age 6 to 59 months old upon study inclusion
- Meet one of the acute malnutrition criteria defined as follows:
- MUAC < 125mm or
- Weight for Length Z-score <-3 (WHO standard) or
- Oedema grade + or ++;
- Resident in health area where the study is conducted ;
- Child's mother or guardian provides informed consent.
Exclusion Criteria:
- Children with medical condition requiring hospitalization or negative appetite test or
oedema grade +++;
- Children allergic to milk, peanuts and/or RUTFs ;
- Children diagnosed with a chronic pathology such as sickle cell anemia, trisomy 21,
congenital heart disease, neurological condition;
- Children currently enrolled in another malnutrition programme.
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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Acute Malnutrition in Infancy (Disorder)
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Intervention(s)
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Dietary Supplement: Nutritional Strategy - ComPAS
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Dietary Supplement: Nutritional Strategy - OptiMA
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Other: National nutritional Strategy (Niger)
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Primary Outcome(s)
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Success rate
[Time Frame: 6-month after randomisation]
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Secondary Outcome(s)
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Recovery rate in children with MUAC<115mm
[Time Frame: Throughout the 6-month observation period]
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Recovery rate in children with SAM WHO definition
[Time Frame: Throughout the 6-month observation period]
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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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