Trial | NCT00418587  Report issue

Title

Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    18
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.
Study Started
Dec 31
2006
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2014
Last Update
Jun 18
2018

Drug Cholecalciferol

800 IU oral daily

  • Other names: Vitamin D3

Drug Cholecalciferol

2000 IU oral daily

  • Other names: Vitamin D3

Drug Cholecalciferol

4000 IU oral daily

  • Other names: Vitamin D3

1 Experimental

800 IU oral daily dose level

2 Experimental

2000 IU oral daily dose level

3 Experimental

4000 IU oral daily dose level

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
No Results Posted