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Modelling an alternative nutrition protocol generalizable for outpatient (MANGO)

Modelling an Alternative Nutrition Protocol Generalizable for Outpatient (MANGO) - effectiveness of an optimized dosage of RUTF for the treatment of severe acute malnutrition: a randomized controlled, non-inferiority trial in Burkina Faso

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50039021
Enrollment
750
Registered
2016-05-13
Start date
2016-10-17
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-complicated severe acute malnutrition among children 6-59 months. Nutritional, Metabolic, Endocrine

Interventions

The intervention tested is restricted to the nutritional treatment of malnourished children involving ready-to use therapeutic foods (RUTFs). The nutritional treatment protocol will be different betwe

Sponsors

ACF France
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 6 to 59 months 2. Diagnosed with uncomplicated SAM and eligible for CMAM treatment, defined as WHZ <-3 and/or MUAC <115mm 3. No pitting bilateral oedema 4. No medical complications 5. Passed a standardized appetite test

Exclusion criteria

Exclusion criteria: 1. Severe anaemia defined as haemoglobin concentration < 4g/dl 2. Plans to leave the catchment area within the next 6 months 3. Known peanut and/or milk allergy 4. Treatment for SAM already received within the last 6 months, including re-admissions after defaulting, relapses, and medical transfers 5. Malformations or handicap which may affect food intake such as cleft palate, cerebral palsy or Down’s syndrome

Design outcomes

Primary

MeasureTime frame
Childrens rate of weight gain (g/kg/d) during treatment, measured at admission, upon weekly visits, and at discharge.

Secondary

MeasureTime frame
1. Duration of treatment (days) until recovery 2. Recovery rate, defaulter rate, mortality rate and transfer to hospital rate, measured monthly 3. Growth velocity and change in anthropometry (weight for height, height for age, weight for age, Mid Upper Arm Circumference), measured on a weekly basis from admission to discharge, and with monthly follow-up measurements during 4 months 4. Relapse rate 4 months after discharge 5. Cost-effectiveness ratio of the intervention to rehabilitate one child 6. Average energy intake (kcal/d) of the child during treatment week number 4 7. Level of vitamin A, iron and inflammation markers in the blood, measured at admission and discharge dates 8. Body composition status at admission and discharge, measuring bio-impedancemetry 9. Level of leptin in the blood, measured at admission, and discharge 10. Catabolism markers in hair, measured at admission, and last follow-up 4 months after discharge

Countries

Burkina Faso

Contacts

Public ContactCécile Salpéteur
csalpeteur@actioncontrelafaim.org+33 1 70 84 73 49

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026