Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

Summary

This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the treatment of severe acute malnutrition.

The main questions are:

1. Does treating children with moderate acute malnutrition using RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with RUSF?
2. Does treating children with uncomplicated severe acute malnutrition using a reduced dose of RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with a standard dose of RUFT?

Secondly, the study will investigate the effect of this alternative protocol compared to the standard protocol on cost-effectiveness, psychomotor development, weight and linear growth and incidence of relapses.

Conditions

• Acute Malnutrition with No Complications

Interventions

DIETARY_SUPPLEMENT

ready-to-use therapeutic food (for children with MAM)

Each child with MAM will be supplemented with RUTF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks.

DIETARY_SUPPLEMENT

Ready-to-use supplementary food

Each child with MAM will be supplemented with RUSF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery

DIETARY_SUPPLEMENT

Ready to Use Therapeutic Food - Reduced dose 1

Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.

DIETARY_SUPPLEMENT

Ready to Use Therapeutic Food - Standard dose

Each child with SAM will be treated with a standard dose (according to the national protocol for the integrated management of acute malnutrition in Burkina Faso) for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery.

DIETARY_SUPPLEMENT

Ready to Use Therapeutic Food - Reduced dose 2

Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until the child is no longer severely malnourished and does not have nutritional oedema then 100-130 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Institut de Recherche en Sciences de la Sante, Burkina Faso

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-31

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Burkina Faso

Study Locations