Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

NCT06792370 | Not Yet Recruiting DMC

• 1 other identifier: INV-016380-2
• Study Type: interventional
• Target: 3,521
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

Acute Malnutrition with No Complications

Keywords

Effectiveness; acute malnutrition; management; treatment; reduced dose; Ready-to-Use Supplementary Foods; Ready-to-Use Therapeutic Foods; uncomplicated; without complication

Outcome Measures

Primary Outcomes (2)

• Rate of programmatic recovery

  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

  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 Outcomes (11)

• Cost per child treated

  From enrollment to the end of treatment (maximum 12 weeks)

• Cost per child recovered

  From enrollment to the end of treatment (maximum 12 weeks)

• 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)

• Daily weight gain

  From enrollment to the exit of the supplementation programme (maximum 12 weeks)]

• Daily length gain

  [Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)

Study Arms (5)

MAM RUTF

EXPERIMENTAL

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)

MAM RUSF

ACTIVE COMPARATOR

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

Dietary Supplement: Ready-to-use supplementary food

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

SAM standard dose RUTF (S-RUTF)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: RUTF

MAM 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

Also known as: RUSF

MAM 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.

Also known as: R-RUTF 1

SAM Reduced-dose RUTF 1 (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.

Also known as: S-RUTF

SAM standard dose RUTF (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.

Also known as: R-RUTF 2

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

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• Failure of appetite test
• Medical complications requiring hospital treatment

Sponsors & Collaborators

• Institut de Recherche en Sciences de la Sante, Burkina Faso: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Institut de Recherche en Sciences de la Santé

Ouagadougou, KADIOGO, Burkina Faso

Location

Related Publications (22)

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MeSH Terms

Interventions

Sarcoglycans

Intervention Hierarchy (Ancestors)

Dystrophin-Associated Proteins; Muscle Proteins; Contractile Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Membrane Glycoproteins

Central Study Contacts

Hermann Biènou LANOU, MD., PhD

CONTACT

+226 66557580; hlanou@yahoo.ca

Seni KOUANDA, MD., PhD

CONTACT

+226 70261462; senikouanda@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Individually randomized and controlled trial

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 24, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)