Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM) (MODAM-MAM)

July 15, 2024 updated by: Heather Stobaugh, Action Against Hunger USA

Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic and Supplementary Foods for the Treatment of Moderate Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia

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 fixed-dose regimen of RUSF for children with MAM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Indi Trehan, MD MPH DTM&H
  • Phone Number: +12067696068
  • Email: itrehan@uw.edu

Study Locations

  • Ethiopia
    • Amhara
      • Sekota, Amhara, Ethiopia
        • Not yet recruiting
        • Sekota
        • Contact:
          • Indi Trehan
    • Oromia
      • Teltele, Oromia, Ethiopia
        • Recruiting
        • Teltele
        • Contact:
          • Indi Trehan
    • Somali Region
      • Gode, Somali Region, Ethiopia
        • Recruiting
        • Gode
        • Contact:
          • Indi Trehan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 6-59 months
  2. 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
  3. Uncomplicated moderate acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
  4. Pass appetite test conducted at the time of enrollment
  5. Consent for randomization into the study given by mother, father, and/or other primary caregiver
  6. Mid-upper arm circumference of 115-124 mm without nutritional edema
  7. Weight-for-height Z-score (WHZ) between -2 and -3

Exclusion Criteria:

  1. 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
  2. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
  3. 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

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
1 sachet (535 kcal) of RUSF per day
Dietary supplement: ready-to-use supplementary food (RUSF)
standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/media/16636/file/S0000248-RUSF-Specification.pdf
Experimental: MAM Experimental A
1 sachet (500 kcal) of RUTF per day
Dietary supplement: ready-to-use therapeutic food (RUTF)
standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
Experimental: MAM Experimental B
2 sachets (1000 kcal) of RUTF per day
Dietary supplement: ready-to-use therapeutic food (RUTF)
standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
short-term nutritional recovery from MAM
Time Frame: up to 16 weeks
two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2, depending on enrollment criteria
up to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
weight gain during treatment
Time Frame: weekly for up to 16 weeks
weekly for up to 16 weeks
mid-upper-arm circumference (MUAC) gain during treatment
Time Frame: weekly for up to 16 weeks
weekly for up to 16 weeks
length/height gain during treatment
Time Frame: weekly for up to 16 weeks
weekly for up to 16 weeks
changes to phase angle (PhA) as measured by bioelectrical impedance analysis
Time Frame: up to weekly for up to 16 weeks
up to weekly for up to 16 weeks
changes to extracellular water (ECW) as measured by bioelectrical impedance analysis
Time Frame: up to weekly for up to 16 weeks
up to weekly for up to 16 weeks
changes to total body water (TBW) as measured by bioelectrical impedance analysis
Time Frame: up to weekly for up to 16 weeks
up to weekly for up to 16 weeks
changes to fat free mass as measured by bioelectrical impedance analysis
Time Frame: up to weekly for up to 16 weeks
up to weekly for up to 16 weeks
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
up to weekly for up to 16 weeks
rates of acute illness, including diarrhea, vomiting, and fever during treatment
Time Frame: weekly for up to 16 weeks
weekly for up to 16 weeks
mortality rate
Time Frame: weekly for up to 16 weeks
weekly for up to 16 weeks
hospitalization rate
Time Frame: weekly for up to 16 weeks
weekly for up to 16 weeks
duration of treatment required prior to short-term recovery
Time Frame: weekly for up to 16 weeks
weekly for up to 16 weeks
medium-term mortality rate
Time Frame: up to 6 months post-recovery
calculated as number of children who die divided by total number of children initially enrolled
up to 6 months post-recovery
medium-term rate of development of acute malnutrition
Time Frame: up to 6 months post-recovery
calculated as number of children who develop acute malnutrition by the total number of children initially enrolled
up to 6 months post-recovery
medium-term rates of relapse to SAM
Time Frame: up to 6 months post-recovery
up to 6 months post-recovery
medium-term rates of relapse to MAM
Time Frame: up to 6 months post-recovery
up to 6 months post-recovery
medium-term rates of hospitalization
Time Frame: up to 6 months post-recovery
up to 6 months post-recovery
medium-term weight gain
Time Frame: 6 months post-recovery
6 months post-recovery
medium-term MUAC gain
Time Frame: 6 months post-recovery
6 months post-recovery
medium-term length/height gain
Time Frame: 6 months post-recovery
6 months post-recovery
medium-term phase angle (PhA) as measured by bioelectrical impedance analysis
Time Frame: 6 months post-recovery
6 months post-recovery
medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis
Time Frame: 6 months post-recovery
6 months post-recovery
medium-term total body water (TBW) as measured by bioelectrical impedance analysis
Time Frame: 6 months post-recovery
6 months post-recovery
medium-term fat free mass as measured by bioelectrical impedance analysis
Time Frame: 6 months post-recovery
6 months post-recovery
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
6 months post-recovery
short-term cost-efficiency
Time Frame: up to 16 weeks
calculated as the total costs of the treatment for all children divided by the number of children who achieve nutritional recovery
up to 16 weeks
medium-term cost-efficiency
Time Frame: 6 months post-recovery
calculated as the total costs of the treatment for all children divided by the number of children who sustain nutritional recovery
6 months post-recovery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Action Against Hunger USA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Washington
Ethiopian Public Health Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather C Stobaugh, Action Against Hunger USA
  • Principal Investigator: Yosef B Asefaw, MSc, Ethiopian Public Health Institute
  • Principal Investigator: Indi Trehan, University of Washington

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MODAM-MAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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