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

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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.


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
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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mi
from
Charleston, SC
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