Supplements, Placebo, or Rosuvastatin Study

• Status: Recruiting
• Trial end date: 2021-11-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: AstraZeneca
• Treatments: Red yeast rice; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.

2. U.S. adults with primary hypercholesterolemia, 40-75 years of age.

3. Not currently taking statins or one of the dietary supplements included in the trial. Patients willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate.

4. LDL-cholesterol between 70 and 189 mg/dL.

5. Patients without diabetes mellitus and a 10-year risk of ASCVD between 5 and <20% using the pooled cohort risk equation. * Or Patients with diabetes mellitus in females 50-60 years of age or males 40-50 years of age with an LDL-C between 70-189 mg/dL and with an ASCVD risk below 20%.

Exclusion Criteria:

1. Age < 40 or >75 years of age

2. Women who are pregnant, plan to become pregnant within the next 6 months, or are breastfeeding.

3. Documented liver dysfunction or history of elevated LFTs indicating active liver disease

4. Documented chronic renal dysfunction within the past two years defined as an eGFR<30mL/min/m2.

5. Known hypersensitivity to rosuvastatin or any supplement under investigation (i.e. shellfish allergy, etc.).

6. Currently taking any prescription statin, or other prescription medication/supplements to treat elevated cholesterol or triglycerides.

7. Currently taking a medication/supplement that has known interaction with rosuvastatin, including fenofibrate, gemfibrozil, HIV medications, colchicine, cyclosporine, warfarin, anti-viral medications to treat Hepatitis C, regorafenib, and darolutamide.

8. Are unwilling to discontinue prohibited dietary supplement(s) for 4 weeks prior to participation or during the course of the trial. Other non-prohibited supplements will be permitted if doses have been stable for at least 4 weeks.

9. Known cardiovascular disease including a history of prior MI, stroke/TIA, PAD or prior revascularization procedures of the heart or vasculature (e.g. CABG, stenting, PCI etc.).

10. Fasting Triglycerides >200mg/dl.

11. In the opinion of the investigator, any other condition that will preclude participation in the study.