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

April 21, 2015 updated by: Avera McKennan Hospital & University Health Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Cholecalciferol
Placebo Comparator: Control
Subjects will take 3 capsules of placebo every day for 14 days
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avera McKennan Hospital & University Health Center

Investigators

  • Principal Investigator: Wael Eid, MD, Avera McKennan Hospital & University Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARI-1350-Myalgia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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