Vitamin D Replacement: The Effect on Statin-Related Myalgias

Overview

The purpose of this project is to determine if Vitamin D supplementation [10,000 international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2011

Interventions

  • Drug: cholecalciferol/placebo
    • 10,000 IU by mouth weekly for 6 months

Arms, Groups and Cohorts

  • Experimental: Vitamin D
    • Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
  • Placebo Comparator: Placebo
    • Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly

Clinical Trial Outcome Measures

Primary Measures

  • Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days) – Patients aged 19-89 years old – Men and women (not of childbearing potential) – Patients receiving statins with concomitant ezetimibe Exclusion Criteria:

  • history of alcoholism or malnutrition – receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Creighton University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Susan Schima, MD, Principal Investigator, Creighton University

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