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

This study has been terminated.
(PI resigned.)
Sponsor:
Information provided by:
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01274104
First received: January 6, 2011
Last updated: July 6, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
 Dietary Supplement: Vitamin D3
Other: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • Brief Pain Inventory value [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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


Enrollment: 0
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Dietary Supplement: Vitamin D3
15,000 IU of Vitamin D3 every day for 14 days
Other Name: Cholecalciferol
Placebo Comparator: Control
Subjects will take 3 capsules of placebo every day for 14 days
 Other: Placebo
Placebo
Other Name: Placebo

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).

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274104

Locations
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Wael Eid, MD Avera McKennan Hospital & University Health Center
  More Information

No publications provided

Responsible Party: Wael Eid, MD, Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01274104     History of Changes
Other Study ID Numbers: ARI-1350-Myalgia
Study First Received: January 6, 2011
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
statin-related myalgia
high cholesterol

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 18, 2012