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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT01911169
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of SLE per 1997 American College of Rheumatology Criteria(at least 4 criteria present)
* Documented Vitamin D deficiency
* Able to give informed consent
Exclusion Criteria:
* Using tobacco products
* Pregnant/Planning pregnancy
* Known Hypercalcemia (Serum Ca \>10.4)
* Known Hypercalcuria (Calcium/Creatinine \>0.8)
* Chronic active lupus nephritis or end stage renal disease or kidney stones
* Known Hyperparathyroidism
* Known chronic viral/mycobacterial infections
* Uncontrolled medical disease - Pl judgment
* Current drug or alcohol abuse
* Anticipated poor compliance/known neuropsychiatric disorders
* Hx of cardiovascular events (i.e. Ml, PVD, CVE)
* Subjects taking medications known to affect FMD in lupus subjects such as but not limited to fish oil, statins, will remain on stable doses throughout the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01911169
Study Brief:
Protocol Section:
NCT01911169