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

January 20, 2025 updated by: Institut de Recherche en Sciences de la Sante, Burkina Faso

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

3521

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hermann Biènou LANOU, MD., PhD
  • Phone Number: +226 66557580
  • Email: hlanou@yahoo.ca

Study Locations

  • Burkina Faso
    • Kadiogo
      • Ouagadougou, Kadiogo, Burkina Faso
        • Institut de Recherche en Sciences de la Santé
        • Contact:
          • Hermann Biènou LANOU, MD., PhD
          • Phone Number: +226 66557580
          • Email: hlanou@yahoo.ca
        • Contact:
          • Seni KOUANDA, MD., PhD
        • Contact:
          • Hermann Bienou LANOU, MD., PhD
        • Contact:
          • Jerome W. SOME, MD., PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

  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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MAM RUTF
Participants with MAM in this arm will receive a dose of 500 kcal/kg/day of RUTF
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.
Other Names:
  • RUTF
Active Comparator: MAM RUSF
Participants with MAM in this arm will receive a dose of 540 kcal/kg/day of RUSF
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
Other Names:
  • RUSF
Experimental: SAM Reduced-dose RUTF 1 (R-RUTF 1)
Participants with SAM in this arm will receive a dose of 150-185 kcal/kg/day of RUTF until programmatic 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.
Other Names:
  • R-RUTF 1
Experimental: SAM Reduced-dose RUTF 2 (R-RUTF 2)
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
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.
Other Names:
  • R-RUTF 2
Active Comparator: SAM standard dose RUTF (S-RUTF)
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
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.
Other Names:
  • S-RUTF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of programmatic recovery
Time Frame: 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
From enrollment to the end of treatment (maximum 12 weeks)
Rate of sustained recovery
Time Frame: 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
from programmatic recovery to 3 months after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost per child treated
Time Frame: 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
From enrollment to the end of treatment (maximum 12 weeks)
Cost per child recovered
Time Frame: 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
From enrollment to the end of treatment (maximum 12 weeks)
Score of the extended version of Developmental Milestones Checklist (DMC-II)
Time Frame: 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.
Three points : enrollment , exit of the supplementation program (up to 12 weeks) and exit of the study (3 months after recovery)
Daily weight gain
Time Frame: 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
From enrollment to the exit of the supplementation programme (maximum 12 weeks)]
Daily length gain
Time Frame: [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)
[Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Energy intake
Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Daily average of calories per kilogram obtained from the 24-hour recall
From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of relapses
Time Frame: 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
from programmatic recovery to 3 months after
Length of stay
Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Duration in days from admission to programmatic recovery
From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of defaulted
Time Frame: 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
From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of treatment failure
Time Frame: 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
From enrollment to the end of treatment (maximum 12 weeks)
Number of adverse events
Time Frame: 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
From enrollment to the exit of the supplementation programme (maximum 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche en Sciences de la Sante, Burkina Faso

Collaborators

Bill and Melinda Gates Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INV-016380-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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