At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 57 enrolled
Drug / intervention
Vitamin D3 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02)
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 3, 2008·Updated Apr 26, 2017
In Brief
A Phase 2 clinical trial evaluating Vitamin D3 and Vitamin D3 placebo for Systemic Lupus Erythematosus and 2 related conditions. Completed, enrolled 57 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus, SLE, Lupus
CountriesUnited States
CollaboratorsAutoimmunity Centers of Excellence
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartNov 2008
Primary CompletionJul 2011
TodayJul 2026
First PostedJul 3, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.0 years ago
Interventions
Vitamin D3drug
8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight
Vitamin D3 placebodrug
86% microcrystalline cellulose, 14% fumed silica by weight