NCT00710021

Vitamin D3 in Systemic Lupus Erythematosus

Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus
• SLE
• Lupus

Interventions

Type	Name	Description
DRUG	Vitamin D3	8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight
DRUG	Vitamin D3 placebo	86% microcrystalline cellulose, 14% fumed silica by weight

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2008-07-03
• Last updated: 2017-04-26
• Results posted: 2014-04-25

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study