Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
This trial is active, not recruiting.
|Condition||systemic lupus erythematosus|
|Sponsor||Medical University of South Carolina|
|Collaborator||American College of Rheumatology Research and Education Foundation|
|Start date||December 2006|
|End date||August 2008|
|Trial size||18 participants|
|Trial identifier||NCT00418587, MUSC-GAC734-HR16356|
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 could be used as a treatment and/or preventative of SLE.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: Monthly
Male or female participants from 18 years up to 85 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)|
|Principal investigator||Diane L Kamen, MD, MSCR|
Call for more information