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Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
simvastatin
red yeast rice
pharmaceutical grade fish oil
therapeutic lifestyle changes
Sponsored by
Chestnut Hill Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemia focused on measuring red yeast rice, pharmaceutical grade fish oil, simvastatin, primary prevention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    LDL-c cholesterol

    Secondary Outcome Measures

    total cholesterol
    HDL
    Triglycerides
    cardiac CRP

    Full Information

    First Posted
    August 16, 2006
    Last Updated
    August 16, 2006
    Sponsor
    Chestnut Hill Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00365742
    Brief Title
    Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements
    Official Title
    Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chestnut Hill Health System

    4. Oversight

    5. Study Description

    Brief 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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipidemia
    Keywords
    red yeast rice, pharmaceutical grade fish oil, simvastatin, primary prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    simvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    red yeast rice
    Intervention Type
    Drug
    Intervention Name(s)
    pharmaceutical grade fish oil
    Intervention Type
    Behavioral
    Intervention Name(s)
    therapeutic lifestyle changes
    Primary Outcome Measure Information:
    Title
    LDL-c cholesterol
    Secondary Outcome Measure Information:
    Title
    total cholesterol
    Title
    HDL
    Title
    Triglycerides
    Title
    cardiac CRP

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Becker
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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