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NCT Number: NCT06061484

Modified Dosage for Severe Acute Malnutrition

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.

Recruiting

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sekota, Amhara, Ethiopia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Ready-to-use therapeutic food (RUTF)

Dietary Supplement

Standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf

Amoxicillin

Drug

Standard weight-based dosing per Ehtiopian national guidelines

Primary outcomes

  1. short-term nutritional recovery from severe acute malnutrition (SAM)

    Time frame: up to 16 weeks

    two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2 and/or resolution of edema, depending on enrollment criteria

Secondary outcomes

  1. weight gain during treatment

    Time frame: weekly for up to 16 weeks

  2. MUAC gain during treatment

    Time frame: weekly for up to 16 weeks

  3. length/height gain during treatment

    Time frame: weekly for up to 16 weeks

  4. changes to phase angle (PhA) as measured by bioelectrical impedance analysis

    Time frame: up to weekly for up to 16 weeks

  5. changes to extracellular water (ECW) as measured by bioelectrical impedance analysis

    Time frame: up to weekly for up to 16 weeks

  6. changes to total body water (TBW) as measured by bioelectrical impedance analysis

    Time frame: up to weekly for up to 16 weeks

  7. changes to fat free mass as measured by bioelectrical impedance analysis

    Time frame: up to weekly for up to 16 weeks

  8. 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

  9. rates of acute illness, including diarrhea, vomiting, and fever during treatment

    Time frame: weekly for up to 16 weeks

  10. mortality

    Time frame: up to 16 weeks

  11. hospitalization

    Time frame: up to 16 weeks

  12. duration of treatment required prior to short-term recovery

    Time frame: up to 16 weeks

  13. medium-term vital status

    Time frame: up to 6 months post-recovery

    calculated as number of children who die divided by total number of children initially enrolled

  14. medium-term nutritional status

    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

  15. medium-term rates of relapse to SAM

    Time frame: up to 6 months post-recovery

  16. medium-term rates of relapse to MAM

    Time frame: up to 6 months post-recovery

  17. medium-term rates of hospitalization

    Time frame: up to 6 months post-recovery

  18. medium-term weight gain

    Time frame: up to 6 months post-recovery

  19. medium-term MUAC gain

    Time frame: up to 6 months post-recovery

  20. medium-term length/height gain

    Time frame: 6 months post-recovery

  21. medium-term phase angle (PhA) as measured by bioelectrical impedance analysis

    Time frame: 6 months post-recovery

  22. medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis

    Time frame: 6 months post-recovery

  23. medium-term total body water (TBW) as measured by bioelectrical impedance analysis

    Time frame: 6 months post-recovery

  24. medium-term fat free mass as measured by bioelectrical impedance analysis

    Time frame: 6 months post-recovery

  25. 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

  26. 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

  27. 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

Study contacts

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

Indi Trehan, MD MPH DTM&H

CONTACT

[email protected]

+12067696068

Sponsors and collaborators

Lead sponsor

Action Against Hunger USA

Other

Collaborators

  • Ethiopian Public Health Institute
  • University of Washington

Registry information

Official study 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

Acronym: MODAM-SAM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2023
Registry last updated
Jul 16, 2024

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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