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NCT Number: NCT06792370

Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

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.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche en Sciences de la Santé

Ouagadougou, KADIOGO, Burkina Faso

Location contact

Hermann Bienou LANOU, MD., PhD

CONTACT

Hermann Biènou LANOU, MD., PhD

CONTACT

[email protected]

+226 66557580

Jerome W. SOME, MD., PhD

CONTACT

Seni KOUANDA, MD., PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.)
  • 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.)

Treatment and study plan

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

Dietary Supplement

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

Ready-to-use supplementary food

Dietary Supplement

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

Ready to Use Therapeutic Food - Reduced dose 1

Dietary Supplement

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

Ready to Use Therapeutic Food - Standard dose

Dietary Supplement

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

Ready to Use Therapeutic Food - Reduced dose 2

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hermann Biènou LANOU, MD., PhD

CONTACT

[email protected]

+226 66557580

Seni KOUANDA, MD., PhD

CONTACT

[email protected]

+226 70261462

Sponsors and collaborators

Lead sponsor

Institut de Recherche en Sciences de la Sante, Burkina Faso

Other Gov

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study title

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

Acronym: Alternat-MAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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