Vitamin D Replacement: The Effect on Statin-Related Myalgias
Primary Purpose
HMG-CoA Reductase Inhibitors-related Myalgias
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol/placebo
Sponsored by
About this trial
This is an interventional treatment trial for HMG-CoA Reductase Inhibitors-related Myalgias focused on measuring Vitamin D3, HMG-CoA reductase inhibitors (statin)-related myalgias
Eligibility 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
Sites / Locations
- The Cardiac Center at Creighton University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01022398
Brief Title
Vitamin D Replacement: The Effect on Statin-Related Myalgias
Official Title
Vitamin D Replacement: The Effect on Statin-Related Myalgias
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Recruitment slow, funding ended.
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HMG-CoA Reductase Inhibitors-related Myalgias
Keywords
Vitamin D3, HMG-CoA reductase inhibitors (statin)-related myalgias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
Intervention Type
Drug
Intervention Name(s)
cholecalciferol/placebo
Other Intervention Name(s)
Vitamin D3/placebo
Intervention Description
10,000 IU by mouth weekly for 6 months
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Schima, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cardiac Center at Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Replacement: The Effect on Statin-Related Myalgias
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