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A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01274104
Recruitment Status : Withdrawn (PI resigned.)
First Posted : January 11, 2011
Last Update Posted : April 22, 2015
Sponsor:
Information provided by:
Avera McKennan Hospital & University Health Center

Tracking Information
First Submitted Date  ICMJE January 6, 2011
First Posted Date  ICMJE January 11, 2011
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
Brief Pain Inventory value [ Time Frame: 14 days ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
Official Title  ICMJE A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Hyperlipidemia
Intervention  ICMJE
  • Dietary Supplement: Vitamin D3
    15,000 IU of Vitamin D3 every day for 14 days
    Other Name: Cholecalciferol
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Vitamin D
    Subjects will take 5,000 IU-capsules of vitamin D3 three times a day (for a total of 15,000 IU) for 14 days
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Control
    Subjects will take 3 capsules of placebo every day for 14 days
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 6, 2011)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2011)
74
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01274104
Other Study ID Numbers  ICMJE ARI-1350-Myalgia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wael Eid, MD, Avera McKennan Hospital & University Health Center
Study Sponsor  ICMJE Avera McKennan Hospital & University Health Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wael Eid, MD Avera McKennan Hospital & University Health Center
PRS Account Avera McKennan Hospital & University Health Center
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP