NCT06792370

Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,521 (estimated)
• Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso · Other Government
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Detailed description

In this trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for severe acute malnutrition (SAM) without complication and 1:1 for moderate acute malnutrition (MAM). Supplementation will be daily according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment will be done. Those who recovered before or at this point will be subsequently followed up monthly for up to 3 months for sustained recovery assessment. Follow-up visits will be done at the health center every week for children with SAM and every two weeks for children with MAM. At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements. The evaluation of the psychomotor development will be performed in a subsample.

Conditions

• Acute Malnutrition with No Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: Burkina Faso