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NCT04846231 · ClinicalTrials.gov registry record · Phase 2
Supplements, Placebo, or Rosuvastatin Study
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 203
- Enrollment target
NCT04846231: Completed Phase 2 study, sponsored by The Cleveland Clinic.
NCT04846231 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 203 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04846231, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 203 participants
- Enrollment target
Study Summary
A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density cholesterol and is sometimes referred to as "bad" cholesterol. Participants must live in Ohio and have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Trial participation is 4 weeks. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.
Primary Outcome
The primary objective of this study is to compare the LDL lowering of rosuvastatin with the effect of six commonly used dietary supplements on cholesterol health.
Interventions
- OTHER Placebo
- DRUG Rosuvastatin
- DIETARY_SUPPLEMENT Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2021-04-23 |
| Est. Completion | 2022-07-19 |
| Phase | Phase 2 |
What the finished NCT04846231 record still lists
NCT04846231 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04846231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04846231 about?
NCT04846231 is a clinical study titled "Supplements, Placebo, or Rosuvastatin Study". A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density c...
What is the current status of trial NCT04846231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2021-04-23. Estimated completion is 2022-07-19.
What interventions are being tested in trial NCT04846231?
The interventions under investigation include: Placebo (OTHER), Rosuvastatin (DRUG), Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04846231?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04846231's enrollment target sits among peer trials
203 301st of 2000 higher than 1,700 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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