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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00418587
First Posted: January 5, 2007
Last Update Posted: August 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
American College of Rheumatology Research and Education Foundation
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Diane Kamen, Medical University of South Carolina
  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
Intervention Model: Single Group Assignment
Masking: None (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 Diane Kamen, Medical University of South Carolina:

Primary Outcome Measures:
  • Hypercalcuria [ Time Frame: Monthly ]

Estimated Enrollment: 18
Study Start Date: December 2006
Study Completion Date: August 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Diane L Kamen, MD, MSCR Medical University of South Carolina
  More Information

Responsible Party: Diane Kamen, Associate Professor of Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00418587     History of Changes
Other Study ID Numbers: MUSC-GAC734-HR16356
First Submitted: January 4, 2007
First Posted: January 5, 2007
Last Update Posted: August 16, 2016
Last Verified: August 2016

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

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