Phase 4
N=11
Is Treatment of Vitamin D Deficiency Associated With Resolution of Statin-Induced Muscular Symptoms
Myopathic Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01568255 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Reduction in Myopathic Pain — 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ergocalciferol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reduction in Myopathic Pain |
4; 4 | — |
| PRIMARY Brief Pain Inventory (BPI) Severity at Exit |
4.5625; 3.8125 | — |
| PRIMARY Vitamin 25 OH D Levels |
18.075; 18.05 | — |
| PRIMARY Brief Pain Inventory (BPI) Interference at Exit |
3.85714285725; 0.80952380967 | — |
| SECONDARY Lipid Profile - Total Cholesterol Levels |
165.8; 197.67 | — |
| SECONDARY Lipid Profile - LDL Cholesterol Levels |
88.4; 106.83 | — |
| SECONDARY Lipid Profile - HDL Cholesterol Levels |
51.8; 63.5 | — |
| SECONDARY Lipid Profile - Triglycerides Levels |
107.54; 86.92 | — |
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
- Female gender (refer to section 4)
- Age > 18, using an effective form of contraception (refer to section 4)
- An indication to be on statin therapy
- Moderate to severe myopathic pain while on Simvastatin
- Serum CK level 1000 IU/day
- Serum creatinine > 2.2 mg/dL within last 6 months
- AST/ALT > 3 x ULN of the local reference range
- Serum CK level > 10 x ULN
- Systolic blood pressure 2.55 mmol/L or < 2.20 mmol/L
- Renal osteodystrophy
- Malabsorption syndrome
- Metastatic malignancy
- Transplant recipients
- A co-existent diagnosis of renal calculi within the previous 6 months
- A co-existent diagnosis of primary hyperparathyroidism within the previous 6 months
- Recent therapy with corticosteroids within the previous 6 months
- Currently consuming Digoxin, as usage increases risk of hypercalcemia
- Lactating women
Data sourced from ClinicalTrials.gov (NCT01568255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.