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

CHU de Quebec-Universite Laval78 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

HMG COA Reductase Inhibitor Adverse Reaction

Interventions

Vitamin DDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centre hospitalier universitaire de Québec - CHUL

Québec, Quebec, Canada

Outcomes

Primary Outcomes

Change in pain score

Time frame: Change from baseline at 2 months

Change in muscle function testing

Strenght and endurance evaluation

Time frame: Change from baseline at 2 months

Secondary Outcomes

Change in muscle histology

Histological, ultrastructural and metabolic assessment of muscle biopsy.

Time frame: Change from baseline at 2 months

Change in pain score

Time frame: Change from baseline at 5 months

Change in muscle function testing

Time frame: Change from baseline at 5 months

Change in muscle histology

Time frame: Change from baseline at 5 months

Data from ClinicalTrials.gov

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