Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition (Alternat-MAL)

Institut de Recherche en Sciences de la Sante, Burkina Faso

Status: Not yet enrolling

Conditions: Acute Malnutrition with No Complications

Treatments: Dietary Supplement: Ready to Use Therapeutic Food - Reduced dose 2; Dietary Supplement: Ready to Use Therapeutic Food - Standard dose; Dietary Supplement: Ready to Use Therapeutic Food - Reduced dose 1; Dietary Supplement: Ready-to-use supplementary food; Dietary Supplement: ready-to-use therapeutic food (for children with MAM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06792370

INV-016380-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,521 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. MAM

   Inclusion Criteria:

   • Anthropometric measures:

     • (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).

   • Age: 6 to 59 months

   • Parents' acceptance of biweekly visits until programme discharge and monthly visits for the post-programme follow up

   Exclusion Criteria:

   • 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
   • History of allergies to peanuts, milk, or soya
   • Relapse from MAM treatment or transfer from SAM treatment
   • Children who have recently (<2 months) taken part in a nutrition programme;
   • Residence outside the study area
   • Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)

2. SAM

Inclusion Criteria:

• Anthropometric measures MUAC< 115 mm or WLZ< - 3 SDs;
• Age: 6-59 months;
• Parents' acceptance of weekly visits until programme discharge and monthly visits for the post-programme follow up.

Exclusion Criteria:

• 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
• History of allergies to peanuts, milk or soya
• Relapse from MAM treatment or transfer from SAM treatment
• Children who have recently (<2 months) taken part in a nutrition programme;
• Residence outside the study area;
• Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,521 participants in 5 patient groups

MAM RUTF

Experimental group

Description:

Participants with MAM in this arm will receive a dose of 500 kcal/kg/day of RUTF

Treatment:

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

MAM RUSF

Active Comparator group

Description:

Participants with MAM in this arm will receive a dose of 540 kcal/kg/day of RUSF

Treatment:

Dietary Supplement: Ready-to-use supplementary food

SAM Reduced-dose RUTF 1 (R-RUTF 1)

Experimental group

Description:

Participants with SAM in this arm will receive a dose of 150-185 kcal/kg/day of RUTF until programmatic recovery

Treatment:

Dietary Supplement: Ready to Use Therapeutic Food - Reduced dose 1

SAM Reduced-dose RUTF 2 (R-RUTF 2)

Experimental group

Description:

Participants with SAM in this arm will receive a 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

Treatment:

Dietary Supplement: Ready to Use Therapeutic Food - Reduced dose 2

SAM standard dose RUTF (S-RUTF)

Active Comparator group

Description:

Participants with SAM in this arm will receive the standard dose of RUTF according to the national protocol for the integrated management of acute malnutrition in Burkina Faso

Treatment:

Dietary Supplement: Ready to Use Therapeutic Food - Standard dose