Clinical Trials Directory

Trials / Completed

CompletedNCT00797407

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

Creatine Supplementation for the Prevention of Statin Myalgia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
The Cleveland Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2006-08-01
Primary completion
2006-12-01
Completion
2006-12-01
First posted
2008-11-25
Last updated
2008-11-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00797407. Inclusion in this directory is not an endorsement.