Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

Not Applicable

Not yet recruiting

• Conditions: Acute Malnutrition with No Complications

• Registration Number: NCT06792370
• Lead Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-12
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3521

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of programmatic recovery	From enrollment to the end of treatment (maximum 12 weeks)	Number of children with a MUAC ≥ 125 mm and WLZ≥ -2 standard deviations for two consecutive visits at or before twelve (12) weeks since admission to the supplementation program in an arm divided by total number of children enrolled in the arm
Rate of sustained recovery	from programmatic recovery to 3 months after	Number of children who maintain a MUAC ≥ 125 mm and WLZ≥ -2 SDs three (03) months after the programmatic recovery in an arm divided by total number of children with a programmatic recovery in the arm

Secondary Outcome Measures

Name	Time	Method
Cost per child treated	From enrollment to the end of treatment (maximum 12 weeks)	Economic metric obtained by dividing the total costs for an arm by the number of children who received treatment in this arm
Cost per child recovered	From enrollment to the end of treatment (maximum 12 weeks)	Economic metric obtained by dividing the total costs for an arm by the number of children recovered in this arm
Score of the extended version of Developmental Milestones Checklist (DMC-II)	Three points : enrollment , exit of the supplementation program (up to 12 weeks) and exit of the study (3 months after recovery)	Psychomotor development of children aged 6-23 months will be assessed by a tool adapted for sub-Saharan Africa countries settings : the extended version of Developmental Milestones Checklist (DMC-II). DMC-II have 76 items and each item is scored from 0 to 2 :zero if the child has not yet started doing the skill, one if the child has been able to perform the skill in the past four weeks but not continually, two if the child has been able to perform the skill for the past four weeks continually. Thus, the minimum value of this score is 0 (indicating no developmental milestones achieved) and the maximum is 152 (full developmental milestones achieved).Higher scores indicate better developmental outcomes, reflecting more advanced motor, language, and personal-social skills.
Energy intake	From enrollment to the exit of the supplementation programme (maximum 12 weeks)	Daily average of calories per kilogram obtained from the 24-hour recall
Daily weight gain	From enrollment to the exit of the supplementation programme (maximum 12 weeks)]	Refers to the increase in weight during the study period and is obtained by dividing the total weight gain in kilogram by the number of days since admission to the exit of the programme
Daily length gain	[Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)	Refers to the increase in length during the study period and is obtained by dividing the total length gain in centimetre by the number of days since admission to the exit of the supplementation programme (maximum 12 weeks)
Rate of relapses	from programmatic recovery to 3 months after	Number of children who return malnourished after programmatic recovery divided by the number of children with programmatic recovery
Length of stay	From enrollment to the exit of the supplementation programme (maximum 12 weeks)	Duration in days from admission to programmatic recovery
Rate of defaulted	From enrollment to the exit of the supplementation programme (maximum 12 weeks)	Number of children absent for three (3) consecutive visits in an arm divided of total number of children enrolled in the arm
Rate of treatment failure	From enrollment to the end of treatment (maximum 12 weeks)	Number of participants with no weight gain after 5 weeks or at the third visit OR weight loss for more than 4 weeks in the program or at the second visit OR weight loss of more than 5% of body weight compared to admission weight at any time OR failure to meet discharge criteria after 3 months in an arm divided by total number of children enrolled in the arm
Number of adverse events	From enrollment to the exit of the supplementation programme (maximum 12 weeks)	Number of incidents in which the use of the dietary supplement or data collection procedures is suspected to have contributed. This can be a physical event (e.g., a rash); a laboratory event (e.g., elevated blood sugar), or an increase in the severity or frequency of a pre-existing symptom or condition

Trial Locations

Locations (1)

Institut de Recherche en Sciences de la Santé; 🇧🇫 Ouagadougou, Kadiogo, Burkina Faso