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

Hypercholesterolemia Clinical Trial

Official title:

Creatine Supplementation for the Prevention of Statin Myalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797407
• Other study ID #: 06-297
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: November 24, 2008
• Start date: August 2006
• Est. completion date: December 2006

Study information

• Verified date: November 2008
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Aches
• Cramps
• Hypercholesterolemia
• Weakness

Intervention

Dietary Supplement:
• Creatine
Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day

Locations

Country	Name	City	State
United States	Wooster Family Health Center, Cleveland Clinic	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined visual analog pain scales (0-10) for aching, cramping and weakness		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	No