Status:
WITHDRAWN
Vitamin D Replacement in Statin-Induced Myopathy
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
HMG COA Reductase Inhibitor Adverse Reaction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- male and female adults
- identified by their physician as having myalgia with their statin medication.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01400009
Start Date
October 1 2010
End Date
July 1 2012
Last Update
April 7 2015
Active Locations (1)
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1
MUHC-Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1