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Completed

NCT Number: NCT00797407

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

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.

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Key information

Conditions

Hypercholesterolemia Aches Asthenia Cramps Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Weakness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wooster Family Health Center, Cleveland Clinic

Wooster, Ohio, 44691, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Creatine

Dietary Supplement

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

Other names: creatine monohydrate

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Creatine Supplementation for the Prevention of Statin Myalgia

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Nov 25, 2008
Registry last updated
Nov 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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