HMG COA Reductase Inhibitor Adverse Reaction
Conditions
Keywords
statins, side effects, muscle, vitamin D, biopsy, strength, fatigue
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.
Interventions
DRUGVitamin D
Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.
DRUGPlacebo
Participants will receive placebo (lactose 100 mg) for 3 months.
Sponsors
Canadian Institutes of Health Research (CIHR)
Laval University
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score | Change from baseline at 2 months | — |
| Change in muscle function testing | Change from baseline at 2 months | Strenght and endurance evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle histology | Change from baseline at 2 months | Histological, ultrastructural and metabolic assessment of muscle biopsy. |
| Change in pain score | Change from baseline at 5 months | — |
| Change in muscle function testing | Change from baseline at 5 months | — |
Countries
Canada
Outcome results
None listed