Vitamin D Replacement in Statin-Induced Myopathy

HMG COA Reductase Inhibitor Adverse Reaction Clinical Trial

Official title:

Vitamin D Replacement in Statin-Induced Myopathy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01400009
• Other study ID #: D-STAT-2010
• Status: Withdrawn
• Phase: N/A
• First received: July 20, 2011
• Last updated: April 6, 2015
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: April 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HMG COA Reductase Inhibitor Adverse Reaction

Intervention

Drug:
• Vitamin D (Cholecalciferol )
10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU
• Placebo
Standard Placebo made of Lactose 100 mg

Locations

Country	Name	City	State
Canada	MUHC-Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	No
Secondary	reduction of visual analog pain score		12 weeks	No