Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05654818
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2022-12-08
Brief Title:
Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects Randomized Single-center Double-blind Trial
Status:
COMPLETED
Status Verified Date:
2024-05
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:
VDSS
Brief Summary:
Vitamin D deficiency is associated with the risk of developing MS Vitamin D treatment has therefore been tested as a background treatment for this pathology with a seemingly modest clinical effect Indeed the first therapeutic trials using high doses of vitamin D SOLAR and CHOLINE did not show a significant effect on short-term relapses However these two studies showed a significant decrease in the radiological activity of MS on MRI suggesting a significant immunomodulatory efficacy but a weak clinical benefit in the short term
Vitamin D has a pleiotropic effect on the immune system inducing overall immunomodulation through transcriptomic modulations under the control of many individual genetic factors However in vivo only one therapeutic trial has compared the immunological effect of Vitamin D in healthy subjects and in patients with a first demyelinating episode Analysis of PBMC by flow cytometric cell sorting based on a very small number of markers CD3 CD8 IL-17 IFN-g did not find any significant quantitative modulation of Th17 or of their production of IL-10 IL-17 and IFN-g after treatment with Vitamin D measured by ELISA However the evolution of anti-inflammatory lymphocyte populations has not been evaluated A few in vitro studies suggest that the effect of vitamin D may be incomplete on the lymphocytes of MS patients
The study investigators will use an immunological FACS approach to describe activation markers and measure the intensity of changes induced in healthy subjects after 3 months of high-dose cholecalciferol versus placebo treatment using the same protocol as the D-Lay MS NCT01817166 study
Vitamin D has a pleiotropic effect on the immune system inducing overall immunomodulation through transcriptomic modulations under the control of many individual genetic factors However in vivo only one therapeutic trial has compared the immunological effect of Vitamin D in healthy subjects and in patients with a first demyelinating episode Analysis of PBMC by flow cytometric cell sorting based on a very small number of markers CD3 CD8 IL-17 IFN-g did not find any significant quantitative modulation of Th17 or of their production of IL-10 IL-17 and IFN-g after treatment with Vitamin D measured by ELISA However the evolution of anti-inflammatory lymphocyte populations has not been evaluated A few in vitro studies suggest that the effect of vitamin D may be incomplete on the lymphocytes of MS patients
The study investigators will use an immunological FACS approach to describe activation markers and measure the intensity of changes induced in healthy subjects after 3 months of high-dose cholecalciferol versus placebo treatment using the same protocol as the D-Lay MS NCT01817166 study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None