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

NCT01274104 | Withdrawn Phase 1 DMC

• 1 other identifier: ARI-1350-Myalgia
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia

Keywords

statin-related myalgia; high cholesterol

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory value

  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

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

Subjects will take 3 capsules of placebo every day for 14 days

Other: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

15,000 IU of Vitamin D3 every day for 14 days

Also known as: Cholecalciferol

Vitamin D

Placebo OTHER

Placebo

Control

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Avera McKennan Hospital & University Health Center: lead

Study Sites (1)

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; Hypercholesterolemia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Wael Eid, MD

  Avera McKennan Hospital & University Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 11, 2011
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

US (1)