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

Condition/Intervention:

  • Statin-induced muscular symptoms

Study Name:

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

Phase:

Pilot

Summary:

The purpose of this study is to examine whether treatment with vitamin D can alleviate statin-induced muscle pain in subjects with vitamin D deficiency. Statins are a class of drugs that are highly effective at lowering cholesterol levels.  However, use of statins is often limited by symptoms of muscle pain.

Vitamin D2 is approved by the U.S. Food and Drug Administration (FDA) to treat various conditions. However, vitamin D has not been systematically studied to test its potential benefits in patients who suffer from statin-induced muscle pain.

Key Inclusion Criteria:

  • At least 18 years old and using an effective form of contraception
  • Indication to be on statin therapy
  • Mild to moderate myopathic (muscle) pain while on a statin
  • Able to continue current statin

Key Exclusion Criteria:

  • Clinical diagnosis of overt vitamin D deficiency: osteomalacia, rickets, hypocalcemia, hypophosphatemia
  • Already taking vitamin D supplements greater than 1000 IU/day
  • Serum creatinine greater than 2.2 mg/dL within the last six months
  • Lactating women

Please see complete list of inclusion and exclusion criteria.

Principal Investigators:

C. Noel Bairey Merz, MD
Margo Minissian, PhDc, ACNP

Co-Investigators:

Chrisandra Shufelt, MD
Puja Mehta, MD
Janet Wei, MD
Talya Waldman, NP

Study Coordinator and Contact:

Margo Minissian, PhDc, ACNP
Phone: 310-423-9927
Email: margo.minissian@cshs.org

Status:

Active

IRB No.:

23187

More Information

Date Last Updated:

06/15