Vitamin D3 in Systemic Lupus Erythematosus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Autoimmunity Centers of Excellence
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00710021
First received: July 1, 2008
Last updated: June 8, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to explore the impact of vitamin D3 on the expression of alpha interferon (IFN alpha) expression in systemic lupus erythematosus (SLE) patients with vitamin D deficiency.


Condition Intervention Phase
Systemic Lupus Erythematosus
Dietary Supplement: Vitamin D3
Dietary Supplement: Vitamin D3 placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Change in expression of an IFN alpha signature among treatment groups [ Time Frame: At Weeks 6 and 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in lupus serology and disease activity [ Time Frame: At Week 12 ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of vitamin D3 supplementation compared with placebo [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 57
Study Start Date: November 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will take vitamin D3 2000 IU orally daily
Dietary Supplement: Vitamin D3
8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight
Other Name: Cholecalciferol
Experimental: 2
Participants will take vitamin D3 4000 IU orally daily
Dietary Supplement: Vitamin D3
8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight
Other Name: Cholecalciferol
Placebo Comparator: 3
Participants will take vitamin D3 placebo orally daily
Dietary Supplement: Vitamin D3 placebo
86% microcrystalline cellulose, 14% fumed silica by weight
Other Name: Cholecalciferol placebo

Detailed Description:

SLE is an autoimmune disease characterized by the production of autoantibodies with subsequent immune complex deposition and tissue inflammation. The role of IFN alpha in the development of SLE has been repeatedly documented. Vitamin D deficiency is common among lupus patients. Vitamin D is recognized as a regulator of immune response. This study will explore the impact of vitamin D3 supplementation on IFN alpha expression in SLE patients.

The study will last approximately 12 weeks and consist of three groups. Group A participants will receive vitamin D3 2000 IU daily. Group B participants will receive vitamin D3 4000 IU daily. Group C participants will receive a vitamin D3 placebo daily. There will be four study visits for each participant. Visits will occur at screening, study entry, and Weeks 6 and 12. Physical examination, vital signs, and blood and urine tests will occur at all visits. For females of childbearing potential, a pregnancy test will be performed at screening and Week 6.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of SLE by ACR criteria
  • Serum 25-OH vitamin D level of 20 ng/ml or less
  • Stable disease at screening, defined as SELENA SLEDAI of 4 or less
  • IFN signature present. More information about this criterion can be found in the protocol.
  • Positive anti-dsDNA antibody at screening
  • If on corticosteroids, the dose must be less than 20 mg per day and stable for 4 weeks prior to screening and at study entry
  • If on immunosuppressive or immunomodulatory medication such as azathioprine, methotrexate, leflunomide, mycophenolate, or hydroxychloroquine, the dose must be stable for 3 months prior to screening and at study entry
  • If receiving a multivitamin or a vitamin D supplement, the dose of vitamin D must be 800 IU daily or less and stable for the 3 months prior to screening and at study entry
  • Agree to use effective contraceptive methods for the duration of the study

Exclusion Criteria:

  • Unwilling to stop using drugs or substances that may interfere with fat absorption
  • Hypercalcemia
  • Hypercalciuria
  • History of hyperparathyroidism
  • History of kidney stones
  • History of cancer, except cervical carcinoma in situ and resected basal and squamous cell carcinomas of the skin
  • Known history of chronic viral infections, including HIV, Hepatitis B, and Hepatitis C
  • Known active tuberculosis
  • Any BILAG A or B manifestation with the exception of a BILAG B mucocutaneous manifestation
  • ALT or AST greater than or equal to two times the upper limit of normal
  • Dialysis or serum creatinine greater than 1.5 mg/dl
  • Expectation by the investigator to increase corticosteroid or immunosuppressive or immunomodulatory medication dose at screening, study entry, or over the course of the study
  • Treatment with cyclophosphomide within 3 months of screening
  • Treatment with rituximab within 12 months of screening
  • Other investigational drug and or treatment during the 4 weeks or seven half lives of the other investigational drug prior to study entry
  • Drug or alcohol abuse within 6 months prior to study entry
  • Treatment with digoxin
  • Treatment with teriparatide
  • Any condition that, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug
  • Pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710021

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Feinstein Institute for Medical Research
Manhassett, New York, United States, 11030
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Autoimmunity Centers of Excellence
Investigators
Study Chair: Cynthia Aranow, MD The Feinstein Institute for Medical Research
Study Chair: Diane Kamen, MD Medical University of South Carolina
  More Information

Publications:
Responsible Party: Associate Director, Clinical Research Program, DAIT/NIAID
ClinicalTrials.gov Identifier: NCT00710021     History of Changes
Other Study ID Numbers: DAIT ALE02
Study First Received: July 1, 2008
Last Updated: June 8, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014