Vitamin D3 in Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Autoimmunity Centers of Excellence
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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