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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Laval University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain score | Change from baseline at 2 months | |
| Change in muscle function testing | Strenght and endurance evaluation | Change from baseline at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle histology | Histological, ultrastructural and metabolic assessment of muscle biopsy. | Change from baseline at 2 months |
| Change in pain score | Change from baseline at 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis R Joanisse, PhD | Laval University | Principal Investigator |
| Jean Bergeron, MD | CHU de Quebec-Universite Laval | Principal Investigator |
| Jérôme Frenette, PhD | CHU de Quebec-Universite Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier universitaire de Québec - CHUL | Québec | Quebec | G1V 4G2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38177036 | Derived | Peyrel P, Mauriege P, Frenette J, Laflamme N, Greffard K, Dufresne SS, Huth C, Bergeron J, Joanisse DR. No benefit of vitamin D supplementation on muscle function and health-related quality of life in primary cardiovascular prevention patients with statin-associated muscle symptoms: A randomized controlled trial. J Clin Lipidol. 2024 Mar-Apr;18(2):e269-e284. doi: 10.1016/j.jacl.2023.12.002. Epub 2023 Dec 15. | |
| 37315062 |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo | Drug | Participants will receive placebo (lactose 100 mg) for 3 months. |
|
| Change in muscle function testing | Change from baseline at 5 months |
| Change in muscle histology | Change from baseline at 5 months |
| Derived |
| 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. |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |