Vitamin D Replacement in Statin-Induced Myopathy

• Status: Withdrawn
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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