NCT03474276

Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old

A Multi-center, Randomized Controlled Comparison of Three Renutrition Strategies for the Management of Moderate Acute Malnutrition Among Children From 6 to 24 Months (Madagascar, Niger, Central African Republic and Senegal)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,357 (actual)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Accepted

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 moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.

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 based on the modulation of the gut microbiota with adjunct product added to standard nutrition flours. The purpose of the MALINEA study is to compare three management strategies for Moderate Acute Malnutrition (MAM) in children aged between 6 months and 2 years old on recovery defined by a weight/size gain at 3 months. The 3 groups will be compared on several anthropometric measurements \[Weight, length, Mid Upper Arm Circumference (MUAC)\], clinical characteristics, adherence and tolerance to interventions between before and after a 3 months intervention Cognitive development of children (Senegal) will also be studied and compared, at inclusion, 3 months and 6 months after inclusion. The investigators will also investigate the microbiomes of malnourished children at inclusion and at 3 and 6 months after inclusion to compare it to the ones of normonourished children.

Conditions

• Moderate Acute Malnutrition

Interventions

Type	Name	Description
DRUG	Azythromycin	Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days
DIETARY_SUPPLEMENT	Inuline and fructo-oligosaccharides	Administration of inuline and fructo-oligosaccharides (Synergy1) 2g/day, mixed with the fortified blend flour given to the child through the whole intervention.
DRUG	Albendazole	Administration of Albendazole at inclusion of the child : 200mgs, one administration
DIETARY_SUPPLEMENT	Fortified blend flour	Children from 6 to 11 months : 200 grams / day Children from 12 to 24 months : 300 grams / day Compostion of the fortified blend flour per 100 grams : either : Mil (whole grains): 58,56 g/100g, Soybeans (fat meal): 16,54g/100g Peanuts (roasted seeds): 8,75g/100g, Cane sugar: 7,35 g/100g Whole milk (Powder): 7,56g/100g, MSV MAM: 0,28g/100g, iodized salt :0,45g/100g, CaC03: 0,48g/100g,Amylase BAN: 0,03g/100g OR Corn (whole grains): 53,29g/100g, Soybeans (dry seeds): 17,82g/100g, Peanuts (roasted seeds): 9,00 g/100g, Cane sugar: 11,00 Whole milk (Powder): 5,00g/100g, Soybean Oil (Purified): 1,24g/100g, Peanut oil (Purified): 1,13g/100g, MSV MAM: 0,27g/100g, iodized salt: 0,53 g/100g, Ca3(PO4)2: 0,62g/100g, KCl: 0,09g/100g

Timeline

• Start date: 2018-01-31
• Primary completion: 2018-12-31
• Completion: 2019-06-30
• First posted: 2018-03-22
• Last updated: 2022-05-24

Locations

4 sites across 4 countries: Central African Republic, Madagascar, Niger, Senegal