Choline to Prevent SAM in Children With MAM (NCT06214897) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Choline to Prevent SAM in Children With MAM
Malawi1,500 participantsStarted 2024-03-18
Plain-language summary
The goal of this clinical trial is to test choline supplementation in children with moderate acute malnutrition in Malawi. The main question it aims to answer is:
Will provision of RUSF with added choline (500mg/day) throughout treatment of moderate acute malnutrition (up to 12 weeks) reduce deterioration to severe acute malnutrition among 6-59 month old Malawian children compared with standard RUSF?
Who can participate
Age range
6 Months – 59 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 6-59 months of age
* uncomplicated MAM (mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm and/or weight-for-length z-score (WLZ) ≥ -3 and \< -2)
* availability for the duration of the study with no plan to move from the catchment area of a participating clinic
Exclusion Criteria:
* presence of nutritional edema
* features of complicated MAM, such as mental status changes or breathing issues
* participation in another feeding program
* known allergy to study food ingredient
* intention to move away from catchment area within 9 months
* developmental delay
* presence of a chronic severe medical condition (other than TB or HIV) such as congenital heart disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of pairwise comparisons with wins of Clinical Benefit, which is a composite of time-to-SAM, graduation, and rate of weight change between enrollment and 4-week follow-up.