High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis. (NCT06381076) | Clinical Trial Compass
CompletedPhase 3
High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.
United States39 participantsStarted 2025-02-03
Plain-language summary
A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey.
Who can participate
Age range
18 Years
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:
* 18 years old or older
* diagnosed with stage 5 CKD.
* receiving hemodialysis at least three months before the trial start date
* All participants can provide signed informed consent, have no dietary restrictions, no food allergies, nor chewing/swallowing difficulties.
Exclusion Criteria:
* Adults with CKD stages 1-4.
* Adults undergoing peritoneal dialysis.
* Pregnant and/or lactating for the duration of the study as confirmed by the dialysis medical staff.
* Use of other IP within 3 months of the initiation of the study.
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.
1This trial tested a high-protein oral supplement combined with liposomal curcumin in people on hemodialysis — given that it's now completed, has the data been published yet, and what did it show about inflammation levels measured by high-sensitivity C-reactive protein?
2Since this was a Phase 3 trial, which suggests researchers already had some confidence in safety and dosing, does the evidence from this study support adding a curcumin-based supplement to my current hemodialysis care plan, or is it still too early to act on the findings?
3People on hemodialysis often have strict dietary and fluid restrictions — would the high-protein component of this supplement be safe and appropriate for my specific kidney function and lab values, or could it put extra strain on my treatment?
4Curcumin can interact with certain medications, including blood thinners and some immunosuppressants — given everything I'm currently taking, is there any reason this kind of supplement could be risky for me specifically?
5If the results of this trial look promising, is this supplement something I could realistically access now through my current care, or would I need to wait for formal clinical guidelines to change before it becomes a recommended option?
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.