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.: PACTR202310844349932 Date of Approval: 06/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Acceptability of Super Cereal Plus with added choline in Malawian children
Official scientific title Acceptability of Super Cereal Plus with added choline in Malawian children
Brief summary describing the background and objectives of the trial Moderate acute malnutrition (MAM) affects approximately 50 million children at any one time worldwide and has an annual incidence likely 3-5x this number. MAM is defined by mid-upper arm circumference >= 11.5 cm and < 12.5 cm or weight-for-length z-score >= -3 and < -2. MAM increases risks of infection, deterioration to severe acute malnutrition (SAM), and death, as well as stunted growth and impaired cognitive development. Supplementary feeding improves outcomes in children with MAM. Despite supplementary feeding, however, some children still deteriorate to SAM or die. In Malawi, this can occur in 5-10% of children, while in other settings such as Sierra Leone, up to 20% of children can deteriorate to SAM, which incurs huge costs both for the child and the health system. Improving the nutrient profile of supplementary foods would have significant implications for food aid. Deficiency of a class of nutrients involved in 1-carbon metabolism has been implicated in the development of kwashiorkor. Chief among these nutrients is choline, which is deficient in the diets of children with or at risk for MAM, as it is largely found in animal-source foods. A planned efficacy trial (CHIME-MAM) aims to determine whether adding a 500mg daily dose of choline to Super Cereal Plus (C-SC+) might reduce deterioration to SAM among Malawian children 6-59 months of age, as compared with standard SC+. In anticipation of CHIME-MAM, this trial aims to determine the acceptability of C-SC+ vs. SC+ 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 supplementary food in children
Anticipated trial start date 31/10/2023
Actual trial start date
Anticipated date of last follow up 14/11/2023
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.06230102 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 Super Cereal Plus with added choline 110g per day of SC+ and 500mg daily of choline (~670mg of choline chloride) 1 week 100g of SC+ contains 410 kcal, 16% protein, 9% fat, 8% dried skim milk powder, 1 RDA of 14 micronutrients. 1 packet of choline will contain 500mg choline (~670mg choline chloride). 50
Control Group Super Cereal Plus with added corn powder 110g per day of SC+, 670g per day of corn powder 1 week 100g of SC+ contains 410 kcal, 16% protein, 9% fat, 8% dried skim milk powder, 1 RDA of 14 micronutrients. 1 packet of corn powder will contain 670mg. 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 the subsequent 3 weeks. 1. Mid-upper arm circumference < 12.5 cm 2. Presence of 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 26/07/2023 Kamuzu University of Health Sciences COMREC
Ethics Committee Address
Street address City Postal code Country
Private Bag 360, Chichira 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 participant consumed the food 3 and 7 days after initiation of each food
Secondary Outcome Manner of Super Cereal Plus preparation 3 and 7 days after initiation of each food
Secondary Outcome How choline vs. corn powder given to child 3 and 7 days after initiation of each food
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mitondo NA NA Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Balchem 200 Boulder Industrial Dr Bridgeton 631044 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 63110 United States of America Professor or Pediatrics
Role Name Email Phone Street address
Principal Investigator Kenneth Maleta kmaleta@kuhes.ac.mw +265888232202 Private Bag 360, Chichiri, 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