Status:
TERMINATED
Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus
Lead Sponsor:
Emory University
Collaborating Sponsors:
Dermatology Foundation
Conditions:
Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Lupus is a disease in which the immune system, which normally fights infection, begins to attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune system attacks is...
Eligibility Criteria
Inclusion
- i. Inclusion Criteria for observational arm:
- Sites: Subjects will be primarily recruited from the Emory and Grady Memorial Hospital Dermatology Clinics. Additional recruitment will be from community dermatologists using a flyer since this is a relatively uncommon skin disease. This study will also be listed on the NIH and Lupus Foundation of America websites.
- Stage of Disease: A previous or new diagnosis of CLE, either clinically supported or confirmed by skin biopsy.
- Age: Adult subjects, greater than 18 years old.
- ii. Inclusion criteria for control group in observational arm: Dermatology patients with skin disease, but without CLE, with skin types IV, V, VI will be recruited for the control group.
- iii. Inclusion criteria for interventional arm: Patients with 25(OH)D levels \<30ng/ml.
- iv. Exclusion Criteria:
- Patients who are already actively having their vitD levels monitored and repleted.
- Patients with 25(OH)D levels ≥30 ng/ml will be excluded from the RCT but are eligible for the observational arm of the study.
- Patients with systemic lupus as defined by the American Rheumatism Association criteria.
- Patients with renal lithiasis, hypercalcemia, inflammatory bowel disease, or sarcoidosis.
- Pregnant patients.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01498406
Start Date
December 1 2011
End Date
June 1 2013
Last Update
November 20 2013
Active Locations (1)
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1
Emory Dermatology Clinics
Atlanta, Georgia, United States, 30322