Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: American College of Rheumatology Research and Education Foundation; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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