HMG COA Reductase Inhibitor Adverse ReactionNCT01493648
Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation
A study testing Vitamin D in people with HMG COA Reductase Inhibitor Adverse Reaction, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HMG COA Reductase Inhibitor Adverse Reaction
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- statin therapy
- healthy and sedentary or moderately physical active
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier universitaire de Québec - CHUL
Québec, Quebec, G1V 4G2
About this study
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.
Read the 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.
- Being tested
- Vitamin D, Placebo
- Keywords
- statins, side effects, muscle, vitamin D, biopsy, strength, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Cholecalciferol, D-tabs
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Not described Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score
Measured: Change from baseline at 2 months
Change in muscle function testing
Strenght and endurance evaluation
Measured: Change from baseline at 2 months
Secondary outcomes (4)
Change in muscle histology
Histological, ultrastructural and metabolic assessment of muscle biopsy.
Measured: Change from baseline at 2 months
Change in pain score
Measured: Change from baseline at 5 months
Change in muscle function testing
Measured: Change from baseline at 5 months
Change in muscle histology
Measured: Change from baseline at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HMG COA Reductase Inhibitor Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Laval University
- Responsible party
- Sponsor
- Investigators
- Denis R Joanisse, PhD, Principal investigator, Laval UniversityJean Bergeron, MD, Principal investigator, CHU de Quebec-Universite LavalJérôme Frenette, PhD, Principal investigator, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493648
- Sponsor's protocol ID
- MOP 114917
- Status last verified
- Jan 2016
- First submitted
- 29 Nov 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38177036Peyrel 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.
PubMed 37315062
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation
- ClinicalTrials.gov ID
- NCT01493648
- Acronym / sponsor ID
- MOP 114917
- Keywords
- statins, side effects, muscle, vitamin D, biopsy, strength, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Laval University
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- statin therapy
- healthy and sedentary or moderately physical active
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Cholecalciferol, D-tabsParticipants will receive weekly doses of 30,000 IU of vitamin D for 3 months. | Drug | Vitamin D |
| PlaceboParticipants will receive placebo (lactose 100 mg) for 3 months. | Drug | Placebo |
Primary outcome
Change in pain score
Time frame: Change from baseline at 2 months
Change in muscle function testing
Time frame: Change from baseline at 2 months
Strenght and endurance evaluation
4 secondary outcomes
Change in muscle histology
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 38177036Peyrel 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.
- Derived from this study: PubMed 37315062Peyrel 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.
Related trials for HMG COA Reductase Inhibitor Adverse Reaction
Recruiting
Exercise Intensity and Muscle Recovery in Statin Users
Statin Adverse Reaction
RecruitingPhase 4
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
Myocardial Infarction, Statin Adverse Reaction
RecruitingPhase 4
DESIFOR-EXPAND (MHIF)
Statin Therapy, Statin Adverse Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis R Joanisse, PhD principal investigator
Laval University
Jean Bergeron, MD principal investigator
CHU de Quebec-Universite Laval
Jérôme Frenette, PhD principal investigator
CHU de Quebec-Universite Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with HMG COA Reductase Inhibitor Adverse Reaction, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score (time frame: Change from baseline at 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01493648, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.