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Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

NCT ID: NCT00365742

Last Updated: 2006-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-06-30

Brief Summary

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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

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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

Conditions

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Hyperlipidemia

Keywords

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red yeast rice pharmaceutical grade fish oil simvastatin primary prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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simvastatin

Intervention Type DRUG

red yeast rice

Intervention Type DRUG

pharmaceutical grade fish oil

Intervention Type DRUG

therapeutic lifestyle changes

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chestnut Hill Health System

OTHER

Sponsor Role lead

Principal Investigators

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David Becker

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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FWA00005390-Chestnut Hill Hosp

Identifier Type: -

Identifier Source: org_study_id