Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation
This study is not yet open for participant recruitment.
Verified December 2011 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborators:
Canadian Institutes of Health Research (CIHR)
Laval University
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01493648
First received: November 29, 2011
Last updated: December 14, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HMG COA Reductase Inhibitor Adverse Reaction |
Drug: Vitamin D Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Primary Outcome Measures:
- Change in pain score [ Time Frame: Change from baseline at 2 months ] [ Designated as safety issue: No ]
- Change in muscle function testing [ Time Frame: Change from baseline at 2 months ] [ Designated as safety issue: No ]Strenght and endurance evaluation
Secondary Outcome Measures:
- Change in muscle histology [ Time Frame: Change from baseline at 2 months ] [ Designated as safety issue: No ]Histological, ultrastructural and metabolic assessment of muscle biopsy.
- Change in pain score [ Time Frame: Change from baseline at 5 months ] [ Designated as safety issue: No ]
- Change in muscle function testing [ Time Frame: Change from baseline at 5 months ] [ Designated as safety issue: No ]
- Change in muscle histology [ Time Frame: Change from baseline at 5 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vitamin D |
Drug: Vitamin D
Participants will receive weekly doses of 40,000 IU of vitamin D for 3 months.
Other Name: Cholecalciferol, D-tabs
|
| Placebo Comparator: Placebo |
Drug: Placebo
Participants will receive placebo (lactose 100 mg) for 3 months.
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493648
Contacts
| Contact: Nathalie Laflamme, MSc | 418-656-4141 ext 47117 | Nathalie.Laflamme@crchul.ulaval.ca |
Locations
| Canada, Quebec | |
| Centre hospitalier universitaire de Québec - CHUL | Not yet recruiting |
| Québec, Quebec, Canada, G1V 4G2 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Canadian Institutes of Health Research (CIHR)
Laval University
Investigators
| Principal Investigator: | Denis R Joanisse, PhD | Laval University |
| Principal Investigator: | Jean Bergeron, MD | Centre Hospitalier Universitaire de Québec, CHU de Québec |
| Principal Investigator: | Jérôme Frenette, PhD | Centre Hospitalier Universitaire de Québec, CHU de Québec |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Québec, CHU de Québec |
| ClinicalTrials.gov Identifier: | NCT01493648 History of Changes |
| Other Study ID Numbers: | MOP 114917 |
| Study First Received: | November 29, 2011 |
| Last Updated: | December 14, 2011 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
|
statins side effects muscle vitamin D |
biopsy strength fatigue |
Additional relevant MeSH terms:
|
Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 21, 2013