Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310496960868 Date of Approval: 06/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Acceptability of a ready-to-use therapeutic food with added choline in Malawian children
Official scientific title Acceptability of a ready-to-use therapeutic food with added choline in Malawian children
Brief summary describing the background and objectives of the trial Severe acute malnutrition (SAM) affects approximately 14 million children worldwide at any one time and has an annual incidence likely 3-5x this number. SAM is defined by wasting (mid-upper arm circumference < 11.5 cm or weight-for-length z-score < -3) or presence of bilateral pedal pitting edema. SAM increases short-term risks for infection, hospitalization, and death, as well as longer-term risks for stunted linear growth and impaired cognitive development. Ready-to-use therapeutic food (RUTF) revolutionized SAM treatment by allowing it to occur in the home setting. RUTF cures most children with SAM and ameliorates its worst consequences. RUTF was designed to improve anthropometry. Since its invention, evidence has accumulated suggesting the original fatty acid content of RUTF is not optimized for cognitive recovery from SAM. A recent trial demonstrated that reducing the omega-6 fatty acid content and adding docosahexaenoic acid (DHA) improved cognitive development 6 months after SAM treatment in Malawian children. Choline plays important roles in brain structure and function and is found primarily in animal-source foods, which are deficient in the diets of children with SAM. A planned efficacy trial (CHIME-SAM) aims to determine whether adding a 500mg daily dose of choline to RUTF (C-RUTF) might improve cognitive recovery from SAM in Malawian children 6-59 months of age, as compared with standard RUTF (S-RUTF). In anticipation of CHIME-SAM, this trial aims to determine the acceptability of C-RUTF vs. S-RUTF in 6-59 month old Malawian children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Acceptability of a novel RUTF in children
Anticipated trial start date 30/10/2023
Actual trial start date
Anticipated date of last follow up 13/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.06230103 Kamuzu University of Health Sciences COMREC
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ready to use therapeutic food with added choline 1 packet per day 1 week 250 mg of choline will be added to each packet of RUTF (C-RUTF). One sachet will provide approximately 530 kcal, 15 g protein, 30 g of fat, 72mg of DHA, and 1 RDA of 14 micronutrients. 50
Control Group Ready to use therapeutic food without added choline 1 packet per day 1 week 2.5 mg of choline will be added to each packet of RUTF (S-RUTF). One sachet will provide approximately 530 kcal, 15 g protein, 30 g of fat, 72 mg of DHA, and 1 RDA of 14 micronutrients. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. 6 - 59 months of age 2. Stated willingness to comply with study procedures and availability during the study, with no plan to move in subsequent 3 weeks 1. Mid-upper arm circumference < 12.5 cm 2. Bilateral pedal pitting edema 3. Allergy to ingredient in food including peanut, milk, fish 4. Receiving a separate supplementary food product from another organization 5. Current participation in a separate research study 6. Indication for immediate hospitalization Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/08/2023 Kamuzu University of Health Sciences COMREC
Ethics Committee Address
Street address City Postal code Country
Private Bag 360, Chichiri BT3 Blantyre NA Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of study food consumed 3 and 7 days after initiation of each food
Primary Outcome Likeability score, scores range from 1-5 with 5 indicated greatest level of likeability 3 and 7 days after initiation of each food
Secondary Outcome Reported vomiting 3 and 7 days after initiation of each food
Secondary Outcome Reported diarrhea 3 and 7 days after initiation of each food
Secondary Outcome Reported rash 3 and 7 days after initiation of each food
Secondary Outcome Number of days over which the participant consumed the food 3 and 7 days after initiation of each food
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makhwira NA NA NA Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Balchem 200 Boulder Industrial Dr Bridgeton 63044 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Washington University in St. Louis 1 Brookings Drive Saint Louis 63130 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Kamuzu University of Health Sciences Private Bag 360, Chichiri BT3 Blantyre NA Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mark Manary manarymj@wustl.edu +13144542341 600 South Euclid Avenue
City Postal code Country Position/Affiliation
Saint Louis United States of America Professor of Pediatrics
Role Name Email Phone Street address
Principal Investigator Kenneth Maleta kmaleta@kuhes.ac.mw +265888232202 Private Bag 360, Chichira, BT3
City Postal code Country Position/Affiliation
Blantyre Malawi Professor of Community and Environmental Health
Role Name Email Phone Street address
Scientific Enquiries Kevin Stephenson k.stephenson@wustl.edu +13144545685 600 South Taylor Avenue, Suite 155
City Postal code Country Position/Affiliation
Saint Louis 63110 United States of America Instructor of Medicine
Role Name Email Phone Street address
Public Enquiries Donna Wegner donnarwegner@wustl.edu +13144547162 600 South Euclid Avenue
City Postal code Country Position/Affiliation
Saint Louis 63110 United States of America Project Manager in the Department of Pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be available. All of the individual participant data collected during the trial will be shared, after deidentification. The study protocol, statistical analysis plan, informed consent form, and analytic code will be shared. The data will be available within 12 months of the primary trial publication. Anyone who wishes to access the data will have access, for any type of analysis purpose. The data will be posted on a public repository. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of primary trial publication None
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information