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

This study is currently recruiting participants.
Verified May 2013 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01568255
First received: March 29, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Myopathic Symptoms
 Drug: Ergocalciferol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Is Treatment of Vitamin D Deficiency Associated With Resolution of Statin-Induced Muscular Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Statins Vitamin D
U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Myopathic pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assess if treatment of vitamin D deficiency improves statin-induced myopathic pain


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D Treatment
Vitamin D Treatment Group
 Drug: Ergocalciferol
Ergocalciferol therapy at 50,000IU for 8 weeks
Placebo Comparator: Placebo Group
Placebo at 50,000IU for 8 weeks
 Drug: Placebo
placebo at 50,000IU for 8 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568255

Contacts
Contact: Margo Minissian, NP 3104239680 margo.minissian@cshs.org
Contact: Ying Mou, PhD 3102487669 ying.mou@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ying Mou, PhD     310-248-7669     ying.mou@cshs.org    
Contact: Rosario Ando     3104239666     rosario.ando@cshs.org    
Sub-Investigator: Margo Minissian, M.D.            
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: C. Noel Bairey Merz, M.D. Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01568255     History of Changes
Other Study ID Numbers: 23187
Study First Received: March 29, 2012
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
myopathic symptoms

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013