Digestive System Nutritional, Metabolic, Endocrine Paediatrics
Conditions
Interventions
First candidate Ready to use therapeutic food made with milk fat globule membrane powder
Standard ready to use therapeutic food made with skimmed milk powder
Sponsors
Washington University in St. Louis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 6-36 months of age 2. Mid-upper arm circumference > 12.4 cm 3. No nutritional edema 4. Stated willingness to comply with study procedures and availability during the study, with no plan to move in subsequent 3 weeks
Exclusion criteria
Exclusion criteria: 1. Allergy to ingredient(s) used in study foods 2. Receiving a separate supplementary food product from another organization 3. Participation in separate research study 4. Indication for immediate hospitalization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of study food consumed. This will be directly observed on clinic days, 0 and 3, for each food, and reported by caregiver for other days not directly observed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Likeability score, scores range from 1-5 with 5 indicating greatest likeability. Caregiver will provide their assessment of likeability. ;Reported vomiting;Reported diarrhea;Reported rash;Number of days over which the participant consumed the food;Estimation for how long it took participant to consume food per day;How likely caregiver feels participant would be to consume this food daily, successfully. | — |
Countries
Sierra Leone
Contacts
Public ContactDonna Wegner
Project Manager in the Department of Pediatrics
Outcome results
None listed