Conditions: Systemic Lupus Erythematosus SLE Lupus
Keywords: Systemic lupus erythematosus SLE Vitamin D3 Vitamin D deficiency IFN alpha expression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 57
Healthy volunteers: no

Brief 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.

Detailed description:
Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies with subsequent immune complex deposition and tissue inflammation. The role of interferon (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 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.

Arms:
arm 1: Participants in this arm take a vitamin D3 dose of 2000 international units (IU) daily by mouth for a duration of 12 weeks. arm 2: Participants in this arm take a vitamin D3 dose of 4000 international units (IU) daily by mouth for a duration of 12 weeks. arm 3: Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks.

Interventions: intervention 1: Vitamin D3 intervention 2: Vitamin D3 placebo
Intervention descriptions: intervention 1: 8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight intervention 2: 86% microcrystalline cellulose, 14% fumed silica by weight

Protocol document: