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

HMG COA Reductase Inhibitor Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493648
• Other study ID #: MOP 114917
• Status: Completed
• Phase: N/A
• First received: November 29, 2011
• Last updated: January 26, 2016
• Start date: December 2011
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• HMG COA Reductase Inhibitor Adverse Reaction

Intervention

Drug:
• Vitamin D
Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.
• Placebo
Participants will receive placebo (lactose 100 mg) for 3 months.

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Québec - CHUL	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	Canadian Institutes of Health Research (CIHR), Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score		Change from baseline at 2 months	No
Primary	Change in muscle function testing	Strenght and endurance evaluation	Change from baseline at 2 months	No
Secondary	Change in muscle histology	Histological, ultrastructural and metabolic assessment of muscle biopsy.	Change from baseline at 2 months	No
Secondary	Change in pain score		Change from baseline at 5 months	No
Secondary	Change in muscle function testing		Change from baseline at 5 months	No
Secondary	Change in muscle histology		Change from baseline at 5 months	No