Systemic Lupus Erythematosus
Conditions
Keywords
Vitamin D, Lupus
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 could be used as a treatment and/or preventative of SLE.
Interventions
DRUGCholecalciferol
800 IU oral daily
Sponsors
American College of Rheumatology Research and Education Foundation
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Medical University of South Carolina
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypercalcuria | Monthly |
Countries
United States
Outcome results
None listed