Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-59
SponsorInstitut de Recherche en Sciences de la Sante, Burkina Faso

About this trial

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.

Eligibility criteria

Qualifiers

MAM

(115 mm ≤ MUAC< 125 mm and -3 SDs ≤ WLZ < -2 SDs) OR

(115 mm ≤ MUAC< 125 mm and WLZ ≥ -2 SDs) OR

(MUAC ≥ 125 mm and -3 SDs ≤ WLZ < -2 SDs).

Disqualifiers

Failure of appetite test

Medical complications requiring hospital treatment

Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection

Presence of bilateral oedema

Trial design

Treatments tested in this trial

  • ready-to-use therapeutic food (for children with MAM)
  • Ready-to-use supplementary food
  • Ready to Use Therapeutic Food - Reduced dose 1
  • Ready to Use Therapeutic Food - Standard dose
  • Ready to Use Therapeutic Food - Reduced dose 2

Treatment groups

3,521 Participants
are divided into 5 treatment groups

Sponsors and collaborators