Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06792370
NA

Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso

View on ClinicalTrials.gov

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.

Official title: Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition in Children Aged 6-59 Months in Burkina Faso: Reduced Dose of RUTF for SAM Children and RUTF Instead of RUSF for MAM Children

Key Details

Gender

All

Age Range

6 Months - 59 Months

Study Type

INTERVENTIONAL

Enrollment

3521

Start Date

2025-05

Completion Date

2026-12

Last Updated

2025-01-24

Healthy Volunteers

No

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.

Locations (1)

Institut de Recherche en Sciences de la Santé

Ouagadougou, KADIOGO, Burkina Faso