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Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

This study has been completed.
Information provided by:
Chestnut Hill Health System Identifier:
First received: August 16, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted

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

Condition Intervention
Hyperlipidemia Drug: simvastatin Drug: red yeast rice Drug: pharmaceutical grade fish oil Behavioral: therapeutic lifestyle changes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial

Resource links provided by NLM:

Further study details as provided by Chestnut Hill Health System:

Primary Outcome Measures:
  • LDL-c cholesterol

Secondary Outcome Measures:
  • total cholesterol
  • HDL
  • Triglycerides
  • cardiac CRP

Estimated Enrollment: 80
Study Start Date: April 2006
Estimated Study Completion Date: June 2006
Detailed 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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00365742

Sponsors and Collaborators
Chestnut Hill Health System
Principal Investigator: David Becker
  More Information Identifier: NCT00365742     History of Changes
Other Study ID Numbers: FWA00005390-Chestnut Hill Hosp
Study First Received: August 16, 2006
Last Updated: August 16, 2006

Keywords provided by Chestnut Hill Health System:
red yeast rice
pharmaceutical grade fish oil
primary prevention

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Red yeast rice
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on September 19, 2017