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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

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

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Vitamin D3

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Other Intervention Names

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Cholecalciferol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No