Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01425775
Status:
COMPLETED
Last Update Posted:
2011-08-30
First Post:
2011-08-18
Brief Title:
The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus SLE
Sponsor:
University of Alexandria
Organization:
University of Alexandria
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic lupus erythematosus SLE is a chronic multi-system inflammatory autoimmune disease Vitamin D has potent immunomodulatory properties that have promoted its potential use in the treatment of autoimmune conditions including SLE We assessed vitamin D status in SLE patients and determined alterations in inflammatory hemostatic markers as well as disease activity before and after vitamin D supplementation
248 SLE patients were enrolled in this randomized placebo-controlled study Patients were randomized 21 to receive either oral cholecalciferol 2000 IUday or placebo for 12 months Outcome measures included assessment of alterations in levels of IL-1 IL-6 IL-18 TNF-alpha Anti-dsDNA ANA fibrinogen and von Willebrand Factor vWF before and after 12 months supplementation Disease activity was measured by the SLEDAI Vitamin D levels were measured by Liaison immunoassay normal 30-100ngml Serum levels between 10-30 ngml were classified as vitamin D insufficiency and levels 10 ngml as vitamin D deficiencyThe mean 25OH D level at baseline was 198 ngml in patients compared to 287 ngml in controls
248 SLE patients were enrolled in this randomized placebo-controlled study Patients were randomized 21 to receive either oral cholecalciferol 2000 IUday or placebo for 12 months Outcome measures included assessment of alterations in levels of IL-1 IL-6 IL-18 TNF-alpha Anti-dsDNA ANA fibrinogen and von Willebrand Factor vWF before and after 12 months supplementation Disease activity was measured by the SLEDAI Vitamin D levels were measured by Liaison immunoassay normal 30-100ngml Serum levels between 10-30 ngml were classified as vitamin D insufficiency and levels 10 ngml as vitamin D deficiencyThe mean 25OH D level at baseline was 198 ngml in patients compared to 287 ngml in controls
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None