Acceptability of a locally produced alternative ready-to-use therapeutic food (RUTF) designed for Ethiopia using a cross-over design

Principal Investigator: Tsinuel Girma1

Co-investigators:  Mark Manary2, Bitiya Admassu1,  Alemseged Abdissa1

Collaborating Institutions: Jimma University, 2) University of Washington
Objective: To show that a new RUTF, custom made for Ethiopia and locally produced, is acceptable to Ethiopian children to ensure that children will consume the food before testing in clinical trial.

Methodology: A 2×2 crossover design testing the acceptability of Ethiopian RUTF (E-RUTF) and control RUTF (C-RUTF) will be employed with 82 children In each arm 50 subjects will be recruited; 100 subjects total will be included to account for a 18% dropout rate. Children aged 8 months to 2 years with moderate malnutrition (MUAC ≥ 11.5 cm and < 12.5 cm) will be enrolled at two sites, Jimma or Serbo town, 50 at each site. A demographic questionnaire will be given and anthropometric measurements of the children taken. Caretaker focus groups will also be carried out to understand the perception of RUTF and local food consumption patterns. The E-RUTF will be given to the children at one site for 7 days while the C- RUTF is given at the other site. Doses of both foods will be 75 kcal/kg/day and both will be packaged is blank foil sachets. After 3 days the caretakers and children will be asked to return to the site for a safety, liking and sharing assessment, and to determine the amount of food consumed by the child to date. After 7 days the mothers and caretakers will return and complete the same assessment and the children will be weighed and measured. The RUTF not given in the first 7 days will then be given. On Day 10 the participants will be asked to return to the site and undergo the same routine as on Day 3. On Day 14, the same routine as Day 10 will be performed with the addition of another caretaker focus group and a preference assessment. A token of appreciation, a suitable piece of clothing, will be given at this time to thank the caretakers for taking their time to participate in the acceptability trial. Also at this time, if a child remains with moderate malnutrition, more food (C-RUTF) will be distributed and health advice given by a trained health professional. Outcomes are the amount of RUTF consumed, child likeability of RUTF as perceived by the caretaker, and no adverse effects from the RUTF.

Funding source: Children’s Investment Fund

Study period: Jan-Dec 2018

Future perspectives: A clinical trial will be conducted using the locally produced food.