Is Treatment of Vitamin D Deficiency Associated With Resolution of Statin-Induced Muscular Symptoms
Condition: Myopathic Symptoms
MeSH terms: Vitamin D Deficiency
Intervention: Ergocalciferol; Placebo
Intervention description: Ergocalciferol therapy at 50,000IU for 8 weeks; placebo at 50,000IU for 8 weeks
Intervention MeSH terms: Ergocalciferols; Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was prospective, randomized, and double blinded pilot Ergocalciferol 50,000 IU once weekly for 8 weeks compared to Placebo in statin myalgic women. Subjects screened for eligibility underwent baseline and exit visits. For baseline and exit visits, subjects had safety labs drawn for lipid and vitamin D levels, completed Brief Pain Inventory (BPI) severity and interference questionnaires, as well as a Short Form (SF-12) questionnaire and medical history.Additionally, subjects underwent physical exams for baseline visits. After physical exams, subjects were then randomized to Placebo or Ergocalciferol treatment.
Masking: Double (Participant, Investigator)
Masking description: This is a randomized, double-blinded, and placebo-controlled pilot study of13 females with moderate to severe myopathic pain while on statins who were enrolled and randomized at a 1:1 ratio.
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: myopathic symptoms

Summary:

      Statins are a class of drugs that are highly effective at lowering cholesterol levels.
      However, compliance is often limited by symptoms of muscle pain. The investigators would like
      to study Vitamin-D deficient individuals who also have muscle pain due to statin use. About 1
      billion people are estimated to have low or insufficient levels of vitamin D worldwide.
      Patients with low or insufficient levels of vitamin D may develop muscle disease. The purpose
      of this study is to identify if these symptoms are associated with vitamin D deficiency, and
      most importantly, if treatment of vitamin D deficiency can reduce muscle pain that is caused
      by statin treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female gender (refer to section 4)

          2. Age > 18, using an effective form of contraception (refer to section 4)

          3. An indication to be on statin therapy

          4. Moderate to severe myopathic pain while on Simvastatin

          5. Serum CK level < 10 x ULN

          6. Vitamin 25 OH D level < 30 ng/mL (as secondary hyperparathyroidism is triggered below
             this level)1

          7. English speaking patients only

          8. Myopathic pain that cannot be attributed to other medical conditions

          9. Continue a statin within the CYP3A4 family

         10. Competent to give informed consent

        Exclusion Criteria:

          1. Clinical diagnosis of overt vitamin D deficiency: osteomalacia, rickets, hypocalcemia,
             hypophosphatemia

          2. Already taking Vitamin D supplements > 1000 IU/day

          3. Serum creatinine > 2.2 mg/dL within last 6 months

          4. AST/ALT > 3 x ULN of the local reference range

          5. Serum CK level > 10 x ULN

          6. Systolic blood pressure < 100 mmHg

          7. Albumin adjusted calcium > 2.55 mmol/L or < 2.20 mmol/L

          8. Renal osteodystrophy

          9. Malabsorption syndrome

         10. Metastatic malignancy

         11. Transplant recipients

         12. A co-existent diagnosis of renal calculi within the previous 6 months

         13. A co-existent diagnosis of primary hyperparathyroidism within the previous 6 months

         14. Recent therapy with corticosteroids within the previous 6 months

         15. Currently consuming Digoxin, as usage increases risk of hypercalcemia

         16. Lactating women