Ignite Creation Date:
2025-12-18 @ 8:43 AM
Ignite Modification Date:
2025-12-18 @ 8:43 AM
Study NCT ID:
NCT03302585
Status:
None
Last Update Posted:
2024-07-24 00:00:00
First Post:
2017-09-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-Dose Vitamin D Induction in Optic Neuritis
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2)
Status:
None
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inability to meet recruitment goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VitaDON2
Brief Summary:
The present trial is based on the observation that vitamin D sufficiency appears to provide some degree of neuroprotection and/or repair in the context of an acute optic neuritis when followed over several months using optical coherence tomography measures. Based on these findings, this randomized double-blinded placebo/standard of care controlled trial has been designed to to see if rapidly inducing vitamin D sufficiency (defined in this trial as a serum 25(OH)D value =\> 80 nmol/L) results in relatively less reduction in neuroaxonal injury and/or improved recovery chronically (at month 12) versus those patients who do not achieve vitamin D sufficiency in the acute optic neuritis period. of Vitamin D. In this trial, 66 patients in total will be randomized to either "high-dose vitamin D induction" treatment group or the "placebo/followed by standard of care vitamin D" group and followed over 12 months.The primary measure of neuroaxonal integrity in this trial is optical coherence tomography outcomes including ganglion cell layer thickness, retinal nerve fiber layer thickness and macular volume. Other vision metrics and magnetic resonance imaging (MRI) measures will provide secondary outcome indicators of this as well.
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?: