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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418587
• Other study ID #: MUSC-GAC734-HR16356
• Status: Completed
• Phase: Phase 1
• Start date: December 2006
• Est. completion date: August 2014

Study information

• Verified date: August 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2014
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Cholecalciferol
800 IU oral daily
• Cholecalciferol
2000 IU oral daily
• Cholecalciferol
4000 IU oral daily

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	American College of Rheumatology Research and Education Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypercalcuria		Monthly