Status:
COMPLETED
Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old
Lead Sponsor:
Institut Pasteur
Collaborating Sponsors:
Action Contre la Faim
Centre de Recherches Médicales et Sanitaires CERMES Niger
Conditions:
Moderate Acute Malnutrition
Eligibility:
All Genders
6-24 years
Phase:
PHASE3
Brief Summary
The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for m...
Detailed Description
The main objective of this study is to improve the nutrition strategy used to take in charge moderate acute malnutrition (MAM) which is the major milestone before severe malnutrition. This will be bas...
Eligibility Criteria
Inclusion
- Children aged from 6 to 24 months olds.
- Moderate acute malnutrition defined by a -3 ≤ Weight/Height z-score \< -2 SD.
- Written informed consent of parents or legal guardian.
- Child able to be brought back to the centre on the two following days of inclusion.
- Child able to be followed up during at least three months.
Exclusion
- Severe malnutrition defined by a mid upper arm circumference \< 115 mm OR Weight/Height z-score \< -3 SD OR presence of nutritional oedema.
- Clinical complications or according to the physician any clinical sign requiring care outside of the recruitment centre (referral to specialised centre or hospitalisation)
- Diarrhea with mucus and bloody stools.
- Current incompatible treatment : Antacids, Cetirizine, Digoxin, Ergotamine, Azidothymidine.
- Known hypersensitivity to macrolides or albendazole (or one of its components)
- Known allergy to enriched flours or prebiotics used in the study, or one of its components.
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
1357 Patients enrolled
Trial Details
Trial ID
NCT03474276
Start Date
January 31 2018
End Date
June 30 2019
Last Update
May 24 2022
Active Locations (4)
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1
Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph
Bangui, Central African Republic, BP 923
2
Institut Pasteur de Madagascar - CRENAM Andohotapenaka et Centre de Santé Mitia
Antananarivo, Madagascar, 101
3
Centre de santé intégré ACF de Tchake et d'Issawanne
Maradi, Niger
4
Institut Pasteur de Dakar - Poste de Santé Hamo V
Dakar, Guédiawaye, Senegal