Overview

This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatments cholecalciferol
Phase phase 1
Sponsor Medical University of South Carolina
Collaborator American College of Rheumatology Research and Education Foundation
Start date December 2006
End date August 2008
Trial size 18 participants
Trial identifier NCT00418587, MUSC-GAC734-HR16356

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
800 IU oral daily dose level
cholecalciferol Vitamin D3
800 IU oral daily
(Experimental)
2000 IU oral daily dose level
cholecalciferol Vitamin D3
2000 IU oral daily
(Experimental)
4000 IU oral daily dose level
cholecalciferol Vitamin D3
4000 IU oral daily

Primary Outcomes

Measure
Hypercalcuria
time frame: Monthly

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
Principal investigator Diane L Kamen, MD, MSCR
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.