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

Primary Purpose

Hypercholesterolemia, Aches, Cramps

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Creatine

About this trial

This is an interventional supportive care trial for Hypercholesterolemia focused on measuring Hydroxymethylglutaryl-CoA Reductase Inhibitors, Creatine, Adverse Effects, Muscle Toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wooster Family Health Center, Cleveland Clinic

Outcomes

Primary Outcome Measures

Combined visual analog pain scales (0-10) for aching, cramping and weakness

Secondary Outcome Measures

Full Information

NCT ID

NCT00797407

First Posted

November 24, 2008

Last Updated

November 24, 2008

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00797407

Brief Title

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

Official Title

Creatine Supplementation for the Prevention of Statin Myalgia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia, Aches, Cramps, Weakness

Keywords

Hydroxymethylglutaryl-CoA Reductase Inhibitors, Creatine, Adverse Effects, Muscle Toxicity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

Creatine

Other Intervention Name(s)

creatine monohydrate

Intervention Description

Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A Shewmon, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wooster Family Health Center, Cleveland Clinic

City

Wooster

State/Province

Ohio

ZIP/Postal Code

44691

Country

United States

12. IPD Sharing Statement

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

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