Vitamin D Replacement in Statin-Induced Myopathy
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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