HMG COA Reductase Inhibitor Adverse ReactionNCT01400009
Vitamin D Replacement in Statin-Induced Myopathy
A study testing Vitamin D (Cholecalciferol ) in people with HMG COA Reductase Inhibitor Adverse Reaction, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HMG COA Reductase Inhibitor Adverse Reaction
- What is being tested?
- Vitamin D (Cholecalciferol )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Jul 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male and female adults
- identified by their physician as having myalgia with their statin medication.
Who cannot join
- Unexplained CK > 4X upper limit of normal, at study entry, or on a statin medication in the past.
- Severe myositis
- Consumption in excess of 14 alcoholic beverages per week
- Situations which will cause difficulty in interpreting the vitamin D and / or PTH.
- examples:
- Present consumption of vitamin D supplements > 1000 iu daily
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- Renal impairment (Estimated creatinine clearance < 70 ± 14 mL/min/m2 in Males; and < 60 ± 10 mL/min/m2 in Females)
- Chronic liver disease or impaired liver function
- Any contraindication for statin re-challenge Example: rhabdomyolysis or allergy to statins
Trial locations and contacts
1 site in 1 country.
About this study
Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.
Read the detailed description
Patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin D or placebo for 6 weeks before reintroducing their statin medication. The investigators will judge whether vitamin D in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.
- Being tested
- Vitamin D (Cholecalciferol ), Placebo
- Keywords
- Statin, HMG COA Reductase Inhibitor, myalgia, vitamin D
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (Cholecalciferol )Drug
Also called DIN number 00821772
10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU
PlaceboDrug
Also called Lactose 100 mg DIN 00501190
Standard Placebo made of Lactose 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study Receives: Drug: Placebo |
| Vitamin D | Active comparator | Subjects in this arm will receive a dose of 50,000 IU of vitamin D3, followed by weekly doses of 10,000 IU of vitamin D3 Receives: Drug: Vitamin D (Cholecalciferol ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
lack of need to stop statin medication due to myalgia
Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia
Measured: 12 weeks
Secondary outcomes (1)
reduction of visual analog pain score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HMG COA Reductase Inhibitor Adverse ReactionStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mark Sherman, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Mark H Sherman, MD,CM, Study chair, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400009
- Sponsor's protocol ID
- D-STAT-2010
- Status last verified
- Apr 2015
- First submitted
- 20 Jul 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Replacement in Statin-Induced Myopathy
- ClinicalTrials.gov ID
- NCT01400009
- Acronym / sponsor ID
- D-STAT-2010
- Keywords
- Statin, HMG COA Reductase Inhibitor, myalgia, vitamin D
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Jul 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.
Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.
Detailed description
Patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin D or placebo for 6 weeks before reintroducing their statin medication. The investigators will judge whether vitamin D in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study |
| Vitamin D | Active comparator | Drug: Vitamin D (Cholecalciferol )Subjects in this arm will receive a dose of 50,000 IU of vitamin D3, followed by weekly doses of 10,000 IU of vitamin D3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male and female adults
- identified by their physician as having myalgia with their statin medication.
Key exclusion criteria (9 listed)
- Unexplained CK > 4X upper limit of normal, at study entry, or on a statin medication in the past.
- Severe myositis
- Consumption in excess of 14 alcoholic beverages per week
- Situations which will cause difficulty in interpreting the vitamin D and / or PTH.
- Present consumption of vitamin D supplements > 1000 iu daily
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 D (Cholecalciferol )Also: DIN number 0082177210,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU | Drug | Vitamin D |
| PlaceboAlso: Lactose 100 mg DIN 00501190Standard Placebo made of Lactose 100 mg | Drug | Placebo |
Primary outcome
lack of need to stop statin medication due to myalgia
Time frame: 12 weeks
Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia
1 secondary outcome
reduction of visual analog pain score
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
Mark H Sherman, MD,CM study chair
McGill University Health Centre/Research Institute of the McGill University Health Centre
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 (Cholecalciferol ) in people with HMG COA Reductase Inhibitor Adverse Reaction, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 9 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: withdrawn, as of the sponsor's last update on 7 Apr 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
lack of need to stop statin medication due to myalgia (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2015.