Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation

NCT ID: NCT01493648

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-01-31

Brief Summary

This proposal will explore muscle function (strength and endurance) in men and women suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle symptoms will be explored. Also, the investigators will assess the potential usefulness of vitamin D supplementation in a randomized control trial.

Detailed Description

Statins are a class of drugs that are widely prescribed to lower blood cholesterol levels. Although they have few side effects, many patients report muscle pain, cramps, and weakness when using these drugs. We know very little on the real impact of these muscle symptoms on patient quality of life, especially in relation to muscle strength and endurance.

Patients under statin therapy will stop medication for 2 months. Results from blood sample, muscle function and muscle biopsy (in some participants) will be compared with baseline. Participants will then take vitamin D supplementation or placebo for one month. Thereafter, statin will be reintroduced for two months while continuing vitamin D or placebo supplementation. At the end of that time, measures from blood sample, muscle function and muscle biopsy will be compared with other visits.

Conditions

HMG COA Reductase Inhibitor Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive placebo (lactose 100 mg) for 3 months.

Interventions

Vitamin D

Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.

Intervention Type: DRUG

Placebo

Participants will receive placebo (lactose 100 mg) for 3 months.

Intervention Type: DRUG

Other Intervention Names

Cholecalciferol, D-tabs

Eligibility Criteria

Inclusion Criteria

• statin therapy
• healthy and sedentary or moderately physical active

Exclusion Criteria

• Current treatment with other lipid-lowering drugs
• Natural medicine affecting lipid metabolism
• CK levels above the normal range
• Clinical vitamin D deficiency
• Impaired liver or kidney function
• Untreated hypo- or hyperthyroidism
• Treatment with other medications known to increase risk of myopathy
• Existing infection requiring antibiotic therapy
• Consumption of greater than 60 ml of grapefruit juice per day
• Inherited muscle disorders or myopathy
• Polymyositis or inflammatory myopathy
• Use of corticosteroids
• Comorbidities resulting in muscle or bone pain
• History of elevated CK
• Unexplained cramps
• Known sickle cell trait
• Cancer within the 5 years prior to study entry
• Diabetes
• Stroke, coronary artery or peripheral vascular disease
• Physical disability or previous injury interfering with exercise testing
• Pregnant or breastfeeding
• Depression (in last 3 years) or treatment with antidepressants
• Use of anti-psychotic drugs
• Alcohol abuse

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis R Joanisse, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Jean Bergeron, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec-Universite Laval

Jérôme Frenette, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec-Universite Laval

Locations

Centre hospitalier universitaire de Québec - CHUL

Québec, Quebec, Canada

Countries

Canada

References

Peyrel P, Mauriege P, Frenette J, Laflamme N, Greffard K, Dufresne SS, Huth C, Bergeron J, Joanisse DR. Impact of statin withdrawal on perceived and objective muscle function. PLoS One. 2023 Jun 14;18(6):e0281178. doi: 10.1371/journal.pone.0281178. eCollection 2023.

Reference Type: DERIVED

PMID: 37315062 (View on PubMed)

Other Identifiers

MOP 114917

Identifier Type: -

Identifier Source: org_study_id