search
Back to results

Modified Dosage for Severe Acute Malnutrition (MODAM-SAM)

Primary Purpose

Severe Acute Malnutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ready-to-use therapeutic food (RUTF)
Amoxicillin
Sponsored by
Action Against Hunger USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 6-59 months Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility Pass appetite test conducted at the time of enrollment Consent for randomization into the study given by mother, father, and/or other primary caregiver Mid-upper arm circumference less than 115 mm and/or nutritional edema Weight-for-height Z-score (WHZ) less than -3 (will not count towards planned sample size) Exclusion Criteria: Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control Group

    SAM Experimental A

    SAM Experimental B

    Arm Description

    Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day

    2 sachets (1000 kcal) of RUTF per day

    2 sachets (1000 kcal) per day while MUAC < 115mm and/or edema and/or WHZ < -3; then decreasing to 1 sachet (500 kcal) per day while MUAC 115-124 and WHZ -2 to -3 and no edema

    Outcomes

    Primary Outcome Measures

    short-term nutritional recovery from severe acute malnutrition (SAM)
    two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2 and/or resolution of edema, depending on enrollment criteria

    Secondary Outcome Measures

    weight gain during treatment
    MUAC gain during treatment
    length/height gain during treatment
    changes to phase angle (PhA) as measured by bioelectrical impedance analysis
    changes to extracellular water (ECW) as measured by bioelectrical impedance analysis
    changes to total body water (TBW) as measured by bioelectrical impedance analysis
    changes to fat free mass as measured by bioelectrical impedance analysis
    changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots
    rates of acute illness, including diarrhea, vomiting, and fever during treatment
    mortality
    hospitalization
    duration of treatment required prior to short-term recovery
    medium-term vital status
    calculated as number of children who die divided by total number of children initially enrolled
    medium-term nutritional status
    calculated as number of children who develop acute malnutrition by the total number of children initially enrolled
    medium-term rates of relapse to SAM
    medium-term rates of relapse to MAM
    medium-term rates of hospitalization
    medium-term weight gain
    medium-term MUAC gain
    medium-term length/height gain
    medium-term phase angle (PhA) as measured by bioelectrical impedance analysis
    medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis
    medium-term total body water (TBW) as measured by bioelectrical impedance analysis
    medium-term fat free mass as measured by bioelectrical impedance analysis
    medium-term immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots
    short-term cost-efficiency
    calculated as the total costs of the treatment for all children divided by the number of children who achieve nutritional recovery
    medium-term cost-efficiency
    calculated as the total costs of the treatment for all children divided by the number of children who sustain nutritional recovery

    Full Information

    First Posted
    September 8, 2023
    Last Updated
    September 24, 2023
    Sponsor
    Action Against Hunger USA
    Collaborators
    University of Washington, Ethiopian Public Health Institute
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06061484
    Brief Title
    Modified Dosage for Severe Acute Malnutrition
    Acronym
    MODAM-SAM
    Official Title
    Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic Food for the Treatment of Severe Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 25, 2023 (Anticipated)
    Primary Completion Date
    September 25, 2026 (Anticipated)
    Study Completion Date
    September 25, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Action Against Hunger USA
    Collaborators
    University of Washington, Ethiopian Public Health Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current weight-based dosing of RUTF for children with SAM.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Acute Malnutrition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day
    Arm Title
    SAM Experimental A
    Arm Type
    Experimental
    Arm Description
    2 sachets (1000 kcal) of RUTF per day
    Arm Title
    SAM Experimental B
    Arm Type
    Experimental
    Arm Description
    2 sachets (1000 kcal) per day while MUAC < 115mm and/or edema and/or WHZ < -3; then decreasing to 1 sachet (500 kcal) per day while MUAC 115-124 and WHZ -2 to -3 and no edema
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    ready-to-use therapeutic food (RUTF)
    Intervention Description
    Standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
    Intervention Type
    Drug
    Intervention Name(s)
    Amoxicillin
    Intervention Description
    Standard weight-based dosing per Ehtiopian national guidelines
    Primary Outcome Measure Information:
    Title
    short-term nutritional recovery from severe acute malnutrition (SAM)
    Description
    two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2 and/or resolution of edema, depending on enrollment criteria
    Time Frame
    up to 16 weeks
    Secondary Outcome Measure Information:
    Title
    weight gain during treatment
    Time Frame
    weekly for up to 16 weeks
    Title
    MUAC gain during treatment
    Time Frame
    weekly for up to 16 weeks
    Title
    length/height gain during treatment
    Time Frame
    weekly for up to 16 weeks
    Title
    changes to phase angle (PhA) as measured by bioelectrical impedance analysis
    Time Frame
    up to weekly for up to 16 weeks
    Title
    changes to extracellular water (ECW) as measured by bioelectrical impedance analysis
    Time Frame
    up to weekly for up to 16 weeks
    Title
    changes to total body water (TBW) as measured by bioelectrical impedance analysis
    Time Frame
    up to weekly for up to 16 weeks
    Title
    changes to fat free mass as measured by bioelectrical impedance analysis
    Time Frame
    up to weekly for up to 16 weeks
    Title
    changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots
    Time Frame
    up to weekly for up to 16 weeks
    Title
    rates of acute illness, including diarrhea, vomiting, and fever during treatment
    Time Frame
    weekly for up to 16 weeks
    Title
    mortality
    Time Frame
    up to 16 weeks
    Title
    hospitalization
    Time Frame
    up to 16 weeks
    Title
    duration of treatment required prior to short-term recovery
    Time Frame
    up to 16 weeks
    Title
    medium-term vital status
    Description
    calculated as number of children who die divided by total number of children initially enrolled
    Time Frame
    up to 6 months post-recovery
    Title
    medium-term nutritional status
    Description
    calculated as number of children who develop acute malnutrition by the total number of children initially enrolled
    Time Frame
    up to 6 months post-recovery
    Title
    medium-term rates of relapse to SAM
    Time Frame
    up to 6 months post-recovery
    Title
    medium-term rates of relapse to MAM
    Time Frame
    up to 6 months post-recovery
    Title
    medium-term rates of hospitalization
    Time Frame
    up to 6 months post-recovery
    Title
    medium-term weight gain
    Time Frame
    up to 6 months post-recovery
    Title
    medium-term MUAC gain
    Time Frame
    up to 6 months post-recovery
    Title
    medium-term length/height gain
    Time Frame
    6 months post-recovery
    Title
    medium-term phase angle (PhA) as measured by bioelectrical impedance analysis
    Time Frame
    6 months post-recovery
    Title
    medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis
    Time Frame
    6 months post-recovery
    Title
    medium-term total body water (TBW) as measured by bioelectrical impedance analysis
    Time Frame
    6 months post-recovery
    Title
    medium-term fat free mass as measured by bioelectrical impedance analysis
    Time Frame
    6 months post-recovery
    Title
    medium-term immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots
    Time Frame
    6 months post-recovery
    Title
    short-term cost-efficiency
    Description
    calculated as the total costs of the treatment for all children divided by the number of children who achieve nutritional recovery
    Time Frame
    up to 16 weeks
    Title
    medium-term cost-efficiency
    Description
    calculated as the total costs of the treatment for all children divided by the number of children who sustain nutritional recovery
    Time Frame
    6 months post-recovery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    59 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 6-59 months Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility Pass appetite test conducted at the time of enrollment Consent for randomization into the study given by mother, father, and/or other primary caregiver Mid-upper arm circumference less than 115 mm and/or nutritional edema Weight-for-height Z-score (WHZ) less than -3 (will not count towards planned sample size) Exclusion Criteria: Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Indi Trehan, MD MPH DTM&H
    Phone
    +12067696068
    Email
    itrehan@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heather C Stobaugh, PhD
    Organizational Affiliation
    Action Against Hunger USA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Indi Trehan, MD MPH DTM&H
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yosef B Asefaw, MSc
    Organizational Affiliation
    Ethiopian Public Health Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Modified Dosage for Severe Acute Malnutrition

    We'll reach out to this number within 24 hrs