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

NCT00797407 | Completed

• 1 other identifier: 06-297
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Aches; Cramps; Weakness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Creatine DIETARY_SUPPLEMENT

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

Also known as: creatine monohydrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Wooster Family Health Center, Cleveland Clinic

Wooster, Ohio, 44691, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia; Pain; Muscle Cramp; Asthenia

Interventions

Creatine

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• David A Shewmon, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: August 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 25, 2008

Record last verified: 2008-11

Locations

US (1)