Status:
COMPLETED
Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
American College of Rheumatology Research and Education Foundation
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D cou...
Eligibility Criteria
Inclusion
- SLE by ACR criteria (revised 1997)
- African American, participating in the SLE in Gullah Health (SLEIGH) Study
- Outpatient
- Stable disease with no BILAG A or B in any system for the past 4 weeks
- Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry
- Baseline 25(OH)D concentration of \< 30 ng/ml
- Willingness to discontinue other vitamin D supplements and/or multivitamins containing vitamin D while participating in the study
- Age 18 - 85 years
- Ability to complete questionnaires in English
- Ability to give informed consent
Exclusion
- Presence of hypercalcemia (\>10.4 mg/dL), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism
- Liver disease (serum ALT, AST \>2x normal) or total serum bilirubin \>1.5x normal
- History of renal stones
- Current treatment with any dose of cyclophosphamide
- Dialysis or creatinine \> 2.5 mg/dL
- Pregnancy
- Current drug or alcohol abuse
- Anticipated poor compliance
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00418587
Start Date
December 1 2006
End Date
August 1 2014
Last Update
June 18 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425