Vitamin D Replacement in Statin-Induced Myopathy

Not Applicable

Withdrawn

• Conditions: HMG COA Reductase Inhibitor Adverse Reaction
• Interventions: Drug: Placebo; Drug: Vitamin D (Cholecalciferol )

• Registration Number: NCT01400009
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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 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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• male and female adults
• identified by their physician as having myalgia with their statin medication.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study
Vitamin D	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

Primary Outcome Measures

Name	Time	Method
lack of need to stop statin medication due to myalgia	12 weeks	Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia

Secondary Outcome Measures

Name	Time	Method
reduction of visual analog pain score	12 weeks

Trial Locations

Locations (1)

MUHC-Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada