CompletedNot Applicable

Development, Feasibility and Acceptability of Recipes for Locally Available, Specially Formulated Foods for the Management of Moderate Acute Malnutrition in Niger (Related to NCT06382857 Protocol)

Niger30 participantsStarted 2022-08-19

Plain-language summary

The study consisted of two phases. Phase 1 was a recipe development phase, which aimed to identify recipes that meet ≥80% of the recommended nutrient profile for Specially Formulated Foods (SFF) used in the standard management of MAM and made with locally available ingredients. In Phase 2, the recipes developed during Phase 1 were evaluated for acceptability among children 6 to \< 24 months of age with MAM during a randomized crossover feeding study with a 30-minute observed test dose and evaluation of at-home use.

Who can participate

Age range6 Months – 23 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Moderate acute malnutrition (MAM) * Eat semi-solid or solid foods for at least 30 days * Written informed consent obtained from the child's legal guardian Exclusion Criteria: * Contraindication/allergy to any locally available ingredient of the LA-SFF recipes generated in Phase 1 Recipe Development * Live outside of the study catchment area or their caregiver planned to move outside of the study catchment area in the next month * Severe acute malnutrition (SAM) * Medical complications requiring hospital based treatment

What they're measuring

Observed test dose acceptability

Timeframe: During 30 minutes of test dose administration

At-home observation acceptability

Timeframe: 12 hours

Trial details

NCT IDNCT07506213

SponsorEpicentre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-11

View on ClinicalTrials.gov More Moderate Acute Malnutrition (MAM) trials