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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. Identifier: NCT01274104
Recruitment Status : Withdrawn (PI resigned.)
First Posted : January 11, 2011
Last Update Posted : April 22, 2015
Information provided by:
Avera McKennan Hospital & University Health Center

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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dietary Supplement: Vitamin D3 Other: Placebo Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : October 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01274104

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

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Responsible Party: Wael Eid, MD, Avera McKennan Hospital & University Health Center Identifier: NCT01274104    
Other Study ID Numbers: ARI-1350-Myalgia
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Avera McKennan Hospital & University Health Center:
statin-related myalgia
high cholesterol
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Neurologic Manifestations
Signs and Symptoms
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents