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

This study has been withdrawn prior to enrollment.
(PI resigned.)
Information provided by:
Avera McKennan Hospital & University Health Center Identifier:
First received: January 6, 2011
Last updated: April 21, 2015
Last verified: April 2015
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
Dietary Supplement: Vitamin D3
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

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

Primary Outcome Measures:
  • 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

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

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).

Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01274104

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

Responsible Party: Wael Eid, MD, Avera McKennan Hospital & University Health Center Identifier: NCT01274104     History of Changes
Other Study ID Numbers: ARI-1350-Myalgia
Study First Received: January 6, 2011
Last Updated: April 21, 2015

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 28, 2017