Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

Hyperlipidemia Clinical Trial

Official title:

Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365742
• Other study ID #: FWA00005390-Chestnut Hill Hosp
• Status: Completed
• Phase: N/A
• First received: August 16, 2006
• Last updated: August 16, 2006
• Start date: April 2006
• Est. completion date: June 2006

Study information

• Verified date: August 2006
• Source: Chestnut Hill Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Randomized trial in a primary prevention population

• all participants have high LDL cholesterol

Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle changes,and take supplements consisting of red yeast rice and fish oil

Description:

This is a randomized primary prevention trial to compare the LDL lowering effects of an alternative regimen to statins(simvastatin) This alternative regimen is over the counter and available at health food stores. The alternative regimen consists of lifestyle changes including a Mediterranean Diet,exercise program, and stress reduction, with red yeast rice 1200 mg twice per day and fish oil 6 grams/day. The second group, run at the same time will take Zocor(simvastatin) 40 mg per day with standard counseling

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults ages 18-75 yrs, who meet ATP III criteria to be treated for high cholesterol. All participants must be able to exercise and be willing to be randomized to either arm of the study

Exclusion Criteria:

• No history of bypass surgery, stents, or hx of myocardial infarction. Cannot have uncontrolled hypertension(SBP>190 or DBP>100), cannot have known intolerance to one of the study drug

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• simvastatin

• red yeast rice

• pharmaceutical grade fish oil

Behavioral:
• therapeutic lifestyle changes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chestnut Hill Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-c cholesterol
Secondary	total cholesterol
Secondary	HDL
Secondary	Triglycerides
Secondary	cardiac CRP