Modified Dosage for Acute Malnutritio

Not Applicable

• Conditions: Nutritional, Metabolic, Endocrine; Paediatrics

• Registration Number: PACTR202309675479831
• Lead Sponsor: Action Against Hunger

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-06
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 8400

Inclusion Criteria

SAM Cohort:
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)

MAM Cohort:
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 (will not count towards planned sample size)

Followup Cohort:
1. Children 6-59 months of old who recovered from SAM or MAM following treatment in either of the SAM or MAM intervention trials

Exclusion Criteria

All Cohorts:
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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SAM cohort -- short-term nutritional recovery from SAM;MAM cohort -- short-term nutritional recovery from MAM<br>;Followup cohort -- number of episodes of relapse to acute malnutrition identified