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

Creatine Supplementation for the Prevention of Statin Myalgia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00797407

Enrollment

Registered

2008-11-25

Start date

2006-08-31

Completion date

2006-12-31

Last updated

2008-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aches, Cramps, Hypercholesterolemia, Weakness

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTCreatine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026