High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe Wasting (NCT05737472) | Clinical Trial Compass
CompletedNot Applicable
High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe Wasting
Malawi128 participantsStarted 2022-11-14
Plain-language summary
This is a proof-of-concept trial that aims to compare the efficacy of an 8-week treatment with higher-protein-Ready-to-Use Therapeutic Foods (RUTF) with standard RUTF in improving levels of markers of growths, height, nutritional recovery, and lean mass deposition among children with severe wasting. The study will also assess the safety and acceptability of the high-protein RUTF in comparison to the standard RUTF. The study will be conducted at four outpatient therapeutic programs in the Blantyre district of Malawi.
Who can participate
Age range
6 Months – 23 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:
* Infants 6-23 months of age with severe wasting at OTP admission according to the WHO criteria: WHZ below -3 or MUAC below 115mm.
* Parent or guardian is able and available to consent
* Children who are able to feed orally in the usual state of health
* The primary caregiver plans to stay in the study area during the duration of the study.
Exclusion Criteria:
* Children with medical complications as per the CMAM guidelines (lack of appetite, severe oedematous malnutrition, acute infections)
* mild and moderate nutritional oedema
* Children with a known terminal illness (e.g. cancer), cerebral palsy (CP), tuberculosis (TB,) HIV infected or exposed
* Children who had SAM in the last 8 weeks, i.e., SAM relapses in the last 8 weeks
* Children admitted to any NRU due to complicated SAM in the previous 4 weeks will also be excluded
* Children whose caregivers refuse to give consent or whose primary givers are not available to give consent
* Children who were previously enrolled in this trial or currently enrolled in this trial whose sibling has also been enrolled in the study
* Children with known intolerance or allergy to high protein diets will be excluded as well as known intolerance or allergy to milk/lactose
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.