Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT01274104
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT01274104
Study Brief:
Protocol Section:
NCT01274104