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

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT00418587
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Primary Completion: 2008-08
• Study Completion: 2014-08
• Status Verified: 2016-08
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cholecalciferol	800 IU oral daily dose level
2	Cholecalciferol	2000 IU oral daily dose level
3	Cholecalciferol	4000 IU oral daily dose level

Primary Outcome Measures

Name	Time	Method
Hypercalcuria	Monthly

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States