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

NCT00418587 | Completed Phase 1 DMC

• 1 other identifier: MUSC-GAC734-HR16356
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Vitamin D; Lupus

Outcome Measures

Primary Outcomes (1)

• Hypercalcuria

  Monthly

Study Arms (3)

1

EXPERIMENTAL

800 IU oral daily dose level

Drug: Cholecalciferol

2

EXPERIMENTAL

2000 IU oral daily dose level

Drug: Cholecalciferol

3

EXPERIMENTAL

4000 IU oral daily dose level

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

800 IU oral daily

Also known as: Vitamin D3

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• American College of Rheumatology Research and Education Foundation: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Diane L Kamen, MD, MSCR

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2007
• First Posted: January 5, 2007
• Study Start: December 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2014
• Last Updated: June 18, 2018

Record last verified: 2016-08

Locations

US (1)