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Vitamin D Replacement: The Effect on Statin-Related Myalgias

This study has been terminated.
(Recruitment slow, funding ended.)
Information provided by (Responsible Party):
Creighton University Identifier:
First received: November 27, 2009
Last updated: March 28, 2013
Last verified: September 2012
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.

Condition Intervention
HMG-CoA Reductase Inhibitors-related Myalgias
Drug: cholecalciferol/placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Replacement: The Effect on Statin-Related Myalgias

Resource links provided by NLM:

Further study details as provided by Creighton University:

Primary Outcome 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 ]

Enrollment: 4
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
Drug: cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Other Name: Vitamin D3/placebo
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
Drug: cholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Other Name: Vitamin D3/placebo


Ages Eligible for Study:   19 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01022398

United States, Nebraska
The Cardiac Center at Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Principal Investigator: Susan Schima, MD Creighton University
  More Information

Responsible Party: Creighton University Identifier: NCT01022398     History of Changes
Other Study ID Numbers: 09-15532
Study First Received: November 27, 2009
Results First Received: March 28, 2013
Last Updated: March 28, 2013

Keywords provided by Creighton University:
Vitamin D3
HMG-CoA reductase inhibitors (statin)-related myalgias

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 26, 2017