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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 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 203 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04846231
The ClinicalTrials.gov registry entry for NCT04846231 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04846231 reports 0 study locations.
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.
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