Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2008-11-30
2011-07-31
Brief Summary
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Detailed Description
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The study will last approximately 12 weeks and consist of three treatment groups: 1.) Participants will receive vitamin D3 2000 IU daily 2.) Participants will receive vitamin D3 4000 IU daily 3.) 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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vitamin D3 2000 IU
Participants in this arm take a vitamin D3 dose of 2000 international units (IU) daily by mouth for a duration of 12 weeks.
Vitamin D3
8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight
vitamin D3 4000 IU
Participants in this arm take a vitamin D3 dose of 4000 international units (IU) daily by mouth for a duration of 12 weeks.
Vitamin D3
8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight
vitamin D3 placebo
Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks.
Vitamin D3 placebo
86% microcrystalline cellulose, 14% fumed silica by weight
Interventions
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Vitamin D3
8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight
Vitamin D3 placebo
86% microcrystalline cellulose, 14% fumed silica by weight
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum 25-OH vitamin D level of 20 ng/mL or less
* Stable disease at screening, defined as a modified Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) of 4 or less
* Interferon (IFN) signature present. More information about this criterion can be found in the protocol
* Positive anti-double-stranded (anti-ds) DNA antibody blood test 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
* 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 human immunodeficiency virus (HIV), Hepatitis B, and Hepatitis C
* Known active tuberculosis
* Any British Isles Lupus Assessment Group (BILAG) A or B manifestation with the exception of a BILAG B mucocutaneous manifestation
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver function tests 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 cyclophosphamide 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
18 Years
ALL
No
Sponsors
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Autoimmunity Centers of Excellence
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Cynthia Aranow, MD
Role: STUDY_CHAIR
Northwell Health
Diane Kamen, MD
Role: STUDY_CHAIR
Medical University of South Carolina
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California, San Francisco
San Francisco, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Feinstein Institute for Medical Research
Manhassett, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Kamen DL, Cooper GS, Bouali H, Shaftman SR, Hollis BW, Gilkeson GS. Vitamin D deficiency in systemic lupus erythematosus. Autoimmun Rev. 2006 Feb;5(2):114-7. doi: 10.1016/j.autrev.2005.05.009. Epub 2005 Jun 21.
Mangini AJ, Lafyatis R, Van Seventer JM. Type I interferons inhibition of inflammatory T helper cell responses in systemic lupus erythematosus. Ann N Y Acad Sci. 2007 Jun;1108:11-23. doi: 10.1196/annals.1422.002.
Tan EM, Cohen AS, Fries JF, Masi AT, McShane DJ, Rothfield NF, Schaller JG, Talal N, Winchester RJ. The 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum. 1982 Nov;25(11):1271-7. doi: 10.1002/art.1780251101.
Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum. 1997 Sep;40(9):1725. doi: 10.1002/art.1780400928. No abstract available.
Isenberg DA, Rahman A, Allen E, Farewell V, Akil M, Bruce IN, D'Cruz D, Griffiths B, Khamashta M, Maddison P, McHugh N, Snaith M, Teh LS, Yee CS, Zoma A, Gordon C. BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford). 2005 Jul;44(7):902-6. doi: 10.1093/rheumatology/keh624. Epub 2005 Apr 6.
Aranow C, Kamen DL, Dall'Era M, Massarotti EM, Mackay MC, Koumpouras F, Coca A, Chatham WW, Clowse ME, Criscione-Schreiber LG, Callahan S, Goldmuntz EA, Keyes-Elstein L, Oswald M, Gregersen PK, Diamond B. Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2015 Jul;67(7):1848-57. doi: 10.1002/art.39108.
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID) website
National Institute of Arthritis and Musculoskeletal and Skin Diseases: Handout on Health-System Lupus Erythematosus
Other Identifiers
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DAIT ALE02
Identifier Type: -
Identifier Source: org_study_id
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