Vitamin D Replacement in Statin-Induced Myopathy

NCT ID: NCT01400009

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-07-31

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.

Conditions

HMG COA Reductase Inhibitor Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Standard Placebo made of Lactose 100 mg

Vitamin D

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

Group Type: ACTIVE_COMPARATOR

Vitamin D (Cholecalciferol )

Intervention Type: DRUG

10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU

Interventions

Vitamin D (Cholecalciferol )

10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU

Intervention Type: DRUG

Placebo

Standard Placebo made of Lactose 100 mg

Intervention Type: DRUG

Other Intervention Names

DIN number 00821772; Lactose 100 mg DIN 00501190

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mark Sherman

Associate Professor (Clinical), Dept of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark H Sherman, MD,CM

Role: STUDY_CHAIR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

MUHC-Royal Victoria Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

D-STAT-2010

Identifier Type: -

Identifier Source: org_study_id