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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Medical University of South Carolina.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
American College of Rheumatology Research and Education Foundation
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00418587
First received: January 4, 2007
Last updated: September 18, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Cholecalciferol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Hypercalcuria [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: December 2006
Estimated Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
800 IU oral daily dose level
Drug: Cholecalciferol
800 IU oral daily
Other Name: Vitamin D3
Experimental: 2
2000 IU oral daily dose level
Drug: Cholecalciferol
2000 IU oral daily
Other Name: Vitamin D3
Experimental: 3
4000 IU oral daily dose level
Drug: Cholecalciferol
4000 IU oral daily
Other Name: Vitamin D3

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418587

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
American College of Rheumatology Research and Education Foundation
Investigators
Principal Investigator: Diane L Kamen, MD, MSCR Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Diane L. Kamen, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00418587     History of Changes
Other Study ID Numbers: MUSC-GAC734-HR16356
Study First Received: January 4, 2007
Last Updated: September 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Vitamin D
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014