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NCT06381076 · ClinicalTrials.gov registry record · Phase 3
High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.
A Phase 3 study of Chronic Kidney Disease 5D, sponsored by University of Florida.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT06381076: Completed Phase 3 study of Chronic Kidney Disease 5D, sponsored by University of Florida.
NCT06381076 is a Phase 3 study of Chronic Kidney Disease 5D that has completed, run by University of Florida. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06381076, a Phase 3 study of Chronic Kidney Disease 5D, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Between-group difference in change from baseline to endline in serum high-sensitivity C-reactive protein (hs-CRP) concentration (mg/L), where higher values indicate greater systemic inflammation. Typical ranges for high-sensitivity C-reactive protein for individuals on hemodialysis is from 5 - 50 mg/L, in which a higher value indicates more inflammation.
Conditions Studied
Interventions
- DRUG Liposomal curcumin
- DRUG Food colorant
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2025-02-03 |
| Est. Completion | 2025-05-13 |
| Phase | Phase 3 |
What the finished NCT06381076 record still lists
NCT06381076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Chronic Kidney Disease 5D appearing as the primary indexed condition, and to 2 interventions - of which Liposomal curcumin is the first listed.
NCT06381076 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06381076 about?
NCT06381076 is a clinical study titled "High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.". 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...
What is the current status of trial NCT06381076?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2025-02-03. Estimated completion is 2025-05-13.
What conditions does trial NCT06381076 study?
This clinical trial studies the following conditions: Chronic Kidney Disease 5D.
What interventions are being tested in trial NCT06381076?
The interventions under investigation include: Liposomal curcumin (DRUG), Food colorant (DRUG).
Who is sponsoring clinical trial NCT06381076?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06381076 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06381076's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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