Equivalency trial of a locally produced alternative ready-to-use therapeutic food (RUTF) in Ghana

• Register: ISRCTN
• Last refreshed on: 29 August 2022
• Main ID: ISRCTN14788669
• Date of registration: 01/12/2017
• Prospective Registration: No
• Primary sponsor: Washington University School of Medicine
• Public title: Equivalency trial of a locally produced alternative ready-to-use therapeutic food (RUTF) in Ghana
• Scientific title: Comparison of a locally produced, alternative therapeutic food to a standard ready-to-use therapeutic food (RUTF) for the treatment of acute malnutrition in children from the Brong Ahafo region of Ghana
• Date of first enrolment: 07/02/2017
• Target sample size: 1800
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14788669
• Study type: Interventional
• Study design: Randomised double-blinded controlled clinical equivalency trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Ghana

Contacts

• Name: Mark Manary

• Name: Meghan Callaghan-Gillespie

Key inclusion & exclusion criteria

Inclusion criteria: Children aged 6-59 months with WHZ < -2, MUAC <12.5 cm, or bipedal edema
Exclusion criteria:
1. Children currently involved in another research trial or feeding program
2. Developmentally delayed
3. Chronic debilitating illness (such as cerebral palsy)
4. History of peanut or milk allergy
5. Serious adverse effects to the study food (such as an allergic reaction)
6. Received therapy for acute malnutrition within one month prior to presentation


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acute malnutrition as defined by weight for height z-score (WHZ) < -2, Mid-Upper Arm Circumference (MUAC) <12.5 cm, or bipedal edema
Nutritional, Metabolic, Endocrine
Malnutrition

Intervention(s)

Randomisation consists of random 1:1 permuted blocks of 4 for the entire study rather than at each study site. Within the randomised blocks two colors were randomly assigned to the intervention group and 2 colors to the control group. To allocate children to a food group, caretakers chose a sealed envelope that contained 1 of 4 colors (permuted randomised blocks). The color will be recorded separately from the child’s clinical measurements and researchers involved in the randomisation process do not know which color corresponds to which food. The drivers who distribute the food will not assess the participant.

Control: ready-to-use therapeutic food (RUTF) - standard formula
Intervention: ready-to-use therapeutic food (RUTF) - alternative formula with locally sourced ingredients

The randomized therapeutic food sufficient for two weeks’ feeding will be given to the enrolled subject’s caretaker with instructions on daily feeding methods and advised not to share the food product with other members of the household. Subjects and caretakers will return for follow-up, food collection, measurements, and monitoring of the child’s growth and any adverse events every two weeks until recovery (WHZ = -2 and MUAC= 12.5 by 12 weeks) or failure (death, transfer to hospital for inpatient care, remaining malnourished at 12 weeks, default). Children with severe acute malnutrition (SAM) will initially be given oral amoxicillin twice daily for a week. For eligible children with no bipedal edema, a MUAC > 11.5 cm and/or WHZ > -3 the child will receive 75 kcal/kg/day of RUTF, for eligible children with bipedal edema or a MUAC < 11.5 or WHZ < -3 the child will receive 190 kcal/kg/day. Once children with SAM achieve MUAC >11.5

Primary Outcome(s)

1. Mid-upper arm circumference, measured with a standard insertion tape to the nearest 0.1 cm every two weeks until recovery
2. Weight for length z-score (weight measured using an electronic scale to the nearest 5 g, length measured to the nearest 0.1 cm using a rigid length board), measured every two weeks until recovery

Secondary Outcome(s)

1. Other anthropometric measures (weight measured using an electronic scale to the nearest 5 g, length measured to the nearest 0.1 cm using a rigid length board), measured every two weeks until recovery
2. Adverse symptoms, such as stomach pain, vomiting, diarrhea, rash or fever, measured every two weeks until recovery

Secondary ID(s)

201604032

Source(s) of Monetary Support

Children's Investment Fund Foundation

Ethics review

Status:
Approval date:
Contact:

1. The Washington University in St. Louis Institutional Review Board, original approval 04/05/2016, continuing review approval 27/04/2017, ref: IRB ID #:201604032 2. Noguchi Memorial Institute for Medical Research Institutional Review Board, original approval 02/03/2016, continuing review approval 04/05/2017, ref: CPN 078/15-16

Results

• Results available: Yes
• Date Completed: 01/04/2018