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
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
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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 May 22, 2013