Effectiveness of Creatine in Preventing Muscle Aching From Cholesterol-Lowering Statin Drugs

November 24, 2008 updated by: The Cleveland Clinic

Creatine Supplementation for the Prevention of Statin Myalgia

The purpose of this study is to determine of creatine will prevent or treat the muscle toxicity side effect of statin drug therapy, whose symptoms are aching, cramping, and weakness. This is tested in patients who have had this side effect from 3 different statin drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Muscle toxicity is the most common limiting side effect of statin therapy. Biochemical studies have suggested the presence of intramuscular creatine deficiency in patients with muscle toxicity. This is a test of oral creatine supplementation in statin intolerant subjects as a method of preventing the onset of this side effect as well as resolving these symptoms when present during statin therapy.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Wooster, Ohio, United States, 44691
        • Wooster Family Health Center, Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hypercholesterolemia in need of aggressive treatment, defined as a high risk of a vascular event, thus subjects with diabetes, pre-diabetes, or known vascular disease
  • intolerance (i.e. muscle toxicity symptoms) of at least 3 statin drugs, each confirmed on rechallenge

Exclusion Criteria:

  • history of elevated CPK or rhabdomyolysis while taking a statin,
  • CPK levels elevated above the normal range at baseline,
  • pregnancy.
  • renal insufficiency, defined as a serum creatinine ≥ 2.0 mg/dl.
  • history of congestive heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined visual analog pain scales (0-10) for aching, cramping and weakness
Time Frame: baseline, after 5 days of creatine loading, after 6 weeks of creatine+statin, after up to 6 weeks on statin without creatine, after 4 days of rechallenge with creatine while still on statin
baseline, after 5 days of creatine loading, after 6 weeks of creatine+statin, after up to 6 weeks on statin without creatine, after 4 days of rechallenge with creatine while still on statin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: David A Shewmon, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (ESTIMATE)

November 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2008

Last Update Submitted That Met QC Criteria

November 24, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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