Modified Dosage for Severe Acute Malnutrition

Severe Acute Malnutrition Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06061484
• Other study ID #: MODAM-SAM
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: September 25, 2026

Study information

• Verified date: September 2023
• Source: Action Against Hunger USA
• Contact: Indi Trehan, MD MPH DTM&H
• Phone: +12067696068
• Email: itrehan[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2400
• Est. completion date: September 25, 2026
• Est. primary completion date: September 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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 severe 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 less than 115 mm and/or nutritional edema

7. Weight-for-height Z-score (WHZ) less than -3 (will not count towards planned sample size)

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

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

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

Drug:
• Amoxicillin
Standard weight-based dosing per Ehtiopian national guidelines

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Action Against Hunger USA	Ethiopian Public Health Institute, University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 16 weeks
Secondary	weight gain during treatment		weekly for up to 16 weeks
Secondary	MUAC gain during treatment		weekly for up to 16 weeks
Secondary	length/height gain during treatment		weekly for up to 16 weeks
Secondary	changes to phase angle (PhA) as measured by bioelectrical impedance analysis		up to weekly for up to 16 weeks
Secondary	changes to extracellular water (ECW) as measured by bioelectrical impedance analysis		up to weekly for up to 16 weeks
Secondary	changes to total body water (TBW) as measured by bioelectrical impedance analysis		up to weekly for up to 16 weeks
Secondary	changes to fat free mass as measured by bioelectrical impedance analysis		up to weekly for up to 16 weeks
Secondary	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		up to weekly for up to 16 weeks
Secondary	rates of acute illness, including diarrhea, vomiting, and fever during treatment		weekly for up to 16 weeks
Secondary	mortality		up to 16 weeks
Secondary	hospitalization		up to 16 weeks
Secondary	duration of treatment required prior to short-term recovery		up to 16 weeks
Secondary	medium-term vital status	calculated as number of children who die divided by total number of children initially enrolled	up to 6 months post-recovery
Secondary	medium-term nutritional status	calculated as number of children who develop acute malnutrition by the total number of children initially enrolled	up to 6 months post-recovery
Secondary	medium-term rates of relapse to SAM		up to 6 months post-recovery
Secondary	medium-term rates of relapse to MAM		up to 6 months post-recovery
Secondary	medium-term rates of hospitalization		up to 6 months post-recovery
Secondary	medium-term weight gain		up to 6 months post-recovery
Secondary	medium-term MUAC gain		up to 6 months post-recovery
Secondary	medium-term length/height gain		6 months post-recovery
Secondary	medium-term phase angle (PhA) as measured by bioelectrical impedance analysis		6 months post-recovery
Secondary	medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis		6 months post-recovery
Secondary	medium-term total body water (TBW) as measured by bioelectrical impedance analysis		6 months post-recovery
Secondary	medium-term fat free mass as measured by bioelectrical impedance analysis		6 months post-recovery
Secondary	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		6 months post-recovery
Secondary	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	up to 16 weeks
Secondary	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	6 months post-recovery