Back to resultsA Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
Primary Purpose
Hyperlipidemia
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Hyperlipidemia focused on measuring statin-related myalgia, high cholesterol
Eligibility Criteria
Inclusion Criteria:
- Men and women who are between the ages of 18 and 88 years old
- A muscle symptom defined as any of the following: Myalgia (muscle aches with normal CK); Myopathy (muscle aches with increased CK up to 5 times above the upper limit of normal); or Myopathy for the purpose of further evaluation (muscle aches with increased CK up to 5 times the upper limit of normal)
Exclusion Criteria:
- Women who are pregnant, breastfeeding or planning to become pregnant
- Morbidly obese with a BMI >40 kg/m2
- Travel to southern states, areas near the Equator, etc., or use of artificial tanning beds, such that study participants have increased sunlight/UV rays exposure in the past 30 days or at any point during the trial
- Currently (within the last 2 weeks) using any of the following supplements: Vitamin D-3 (Cholecalciferol) of more than 400 IU orally daily, which would not exclude typical multi-vitamin use; Vitamin D-2 (Ergocalciferol); Calcitriol; or Coenzyme Q10
- Documented to be hyperglycemic or laboratory results show hyperglycemia prior to randomization
- Renal dysfunction defined as glomerular filtration rate less than 60 mL/min.
- Documented to have parathyroid abnormalities or parathyroid hormone laboratory results show the study participant is outside of the normal limits
Sites / Locations
- Avera Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D
Control
Arm Description
Subjects will take 5,000 IU-capsules of vitamin D3 three times a day (for a total of 15,000 IU) for 14 days
Subjects will take 3 capsules of placebo every day for 14 days
Outcomes
Primary Outcome Measures
Brief Pain Inventory value
Decrease in the level of muscle pain, based on values of Brief Pain Inventory short forms completed at the initial clinic visit and approximately four weeks later at the final clinic visit
Secondary Outcome Measures
Full Information
NCT ID
NCT01274104
First Posted
January 6, 2011
Last Updated
April 21, 2015
Sponsor
Avera McKennan Hospital & University Health Center
1. Study Identification
Unique Protocol Identification Number
NCT01274104
Brief Title
A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
Official Title
A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI resigned.
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Avera McKennan Hospital & University Health Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain or aches that may be caused by taking certain medications for treating high cholesterol.
Detailed Description
Participation in this study will consist of at least two study visits, expected to occur over a period of up to four weeks. Study-related medication will be provided at no cost to participants. Participants will receive either Vitamin D or placebo (sugar pill).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
statin-related myalgia, high cholesterol
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Subjects will take 5,000 IU-capsules of vitamin D3 three times a day (for a total of 15,000 IU) for 14 days
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects will take 3 capsules of placebo every day for 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
15,000 IU of Vitamin D3 every day for 14 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Brief Pain Inventory value
Description
Decrease in the level of muscle pain, based on values of Brief Pain Inventory short forms completed at the initial clinic visit and approximately four weeks later at the final clinic visit
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women who are between the ages of 18 and 88 years old
A muscle symptom defined as any of the following: Myalgia (muscle aches with normal CK); Myopathy (muscle aches with increased CK up to 5 times above the upper limit of normal); or Myopathy for the purpose of further evaluation (muscle aches with increased CK up to 5 times the upper limit of normal)
Exclusion Criteria:
Women who are pregnant, breastfeeding or planning to become pregnant
Morbidly obese with a BMI >40 kg/m2
Travel to southern states, areas near the Equator, etc., or use of artificial tanning beds, such that study participants have increased sunlight/UV rays exposure in the past 30 days or at any point during the trial
Currently (within the last 2 weeks) using any of the following supplements: Vitamin D-3 (Cholecalciferol) of more than 400 IU orally daily, which would not exclude typical multi-vitamin use; Vitamin D-2 (Ergocalciferol); Calcitriol; or Coenzyme Q10
Documented to be hyperglycemic or laboratory results show hyperglycemia prior to randomization
Renal dysfunction defined as glomerular filtration rate less than 60 mL/min.
Documented to have parathyroid abnormalities or parathyroid hormone laboratory results show the study participant is outside of the normal limits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael Eid, MD
Organizational Affiliation
Avera McKennan Hospital & University Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
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