Is Treatment of Vitamin D Deficiency Associated With Resolution of Statin-Induced Muscular Symptoms

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Ergocalciferols; Vitamin D; Vitamins

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