Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
Status: | Completed |
---|---|
Conditions: | Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 6/20/2018 |
Start Date: | December 2006 |
End Date: | August 2014 |
Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
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.
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.
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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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