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Vitamin D Replacement: The Effect on Statin-Related Myalgias

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ClinicalTrials.gov Identifier: NCT01022398
Recruitment Status : Terminated (Recruitment slow, funding ended.)
First Posted : December 1, 2009
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Creighton University

Brief Summary:
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 or disease Intervention/treatment Phase
HMG-CoA Reductase Inhibitors-related Myalgias Drug: cholecalciferol/placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Replacement: The Effect on Statin-Related Myalgias
Study Start Date : February 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022398


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

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01022398     History of Changes
Other Study ID Numbers: 09-15532
First Posted: December 1, 2009    Key Record Dates
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013
Last Verified: September 2012

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

Additional relevant MeSH terms:
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents