Vitamin D3 in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus; SLE; Lupus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Vitamin D3; Vitamin D3 placebo
Intervention description: 8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight; 86% microcrystalline cellulose, 14% fumed silica by weight
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systemic lupus erythematosus; SLE; Vitamin D3; Vitamin D deficiency; IFN alpha expression

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of SLE by American College of Rheumatology (ACR) 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:

          -  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 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