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

NCT01568255 | Completed Phase 4 Results

• 1 other identifier: 23187
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopathic Symptoms

Keywords

myopathic symptoms

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Reduction in Myopathic Pain

  To investigate if Vitamin D therapy reduces myopathic pain in subjects on statin medication who have low vitamin D levels and experience myopathic pain.

  8 weeks

• Brief Pain Inventory (BPI) Severity at Exit

  Brief Pain Inventory (BPI) severity and interference questionnaires. BPI Severity Scale from 0 (Low Pain) to 10 (High Pain).

  8 weeks

• Vitamin 25 OH D Levels

  Assessed with serum measurements

  8 weeks

• Brief Pain Inventory (BPI) Interference at Exit

  Brief Pain Inventory (BPI) severity and interference questionnaires. BPI Severity on a scale from 1 (Low Interference) to 10 (High Interference).

  8 weeks

Secondary Outcomes (4)

• Lipid Profile - Total Cholesterol Levels

  8 weeks

• Lipid Profile - LDL Cholesterol Levels

  8 weeks

• Lipid Profile - HDL Cholesterol Levels

  8 weeks

• Lipid Profile - Triglycerides Levels

  8 weeks

Study Arms (2)

Vitamin D Treatment

EXPERIMENTAL

Vitamin D Treatment Group

Drug: Ergocalciferol

Placebo Group

PLACEBO COMPARATOR

Placebo at 50,000IU for 8 weeks

Drug: Placebo

Interventions

Ergocalciferol DRUG

Ergocalciferol therapy at 50,000IU for 8 weeks

Vitamin D Treatment

Placebo DRUG

placebo at 50,000IU for 8 weeks

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 10 x ULN
• Vitamin 25 OH D level \< 30 ng/mL (as secondary hyperparathyroidism is triggered below this level)1
• English speaking patients only
• Myopathic pain that cannot be attributed to other medical conditions
• Continue a statin within the CYP3A4 family
• Competent to give informed consent

You may not qualify if:

• Clinical diagnosis of overt vitamin D deficiency: osteomalacia, rickets, hypocalcemia, hypophosphatemia
• Already taking Vitamin D supplements \> 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 \< 100 mmHg
• Albumin adjusted calcium \> 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Ergocalciferols

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Margo Minissian, PhD
• Organization: Cedars Sinai

Margo.Minissian@cshs.org

310-423-5195

Study Officials

• Margo B. Minissian, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Brawerman Nursing Institute

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data is currently available
• Access Criteria: We plan to submit manuscript for peer review.

Locations

US (1)