Optic Neuritis Clinical Trial
— VitaDON2Official title:
A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2)
This is a phase II randomized double-blind placebo/standard of care trial to determine if rapidly inducing vitamin D sufficiency in patients with acute optic neuritis results in less damage/greater recovery at 12 months as measured by optical coherence tomography, visual evoked potentials, visual acuity and radiological measures. Our hypothesis, based on earlier observational studies, is that acute optic neuritis in the context of vitamin D sufficiency results in better visual outcomes compared to those that are not sufficient acutely, regardless of such interventions as steroid therapy.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | April 2023 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Canadian residents - Patients must be between age 18 and 45 years - Patients must have a diagnosis of either a CIS or RRMS (according to McDonald criteria) - Patients must have an EDSS of 5.5 or less - Patients must demonstrate features of a first typical optic neuritis within 21 days of recruitment (or must initiate treatment by day 30) - Patients must have a baseline 25(OH)D < 80 nmol/L regardless of vitamin D3 supplementation - Patients must have no contraindications to high-dose vitamin D supplementation - Female patients must consent to use a reliable form of contraception (oral contraceptive pill, intrauterine device, barrier methods, abstinence) for the duration of the active treatment phase (first 90 days of where study drug provided) of the trial - Patients must provide written informed consent. Exclusion Criteria: - Patients who have had a previous optic neuritis - Patients with evidence of a non-inflammatory cause of optic neuropathy - Patients with evidence of neuromyelitis optica spectrum disorder or "NMOSD" (i.e. bilateral optic neuritis, MRI evidence of longitudinally enhancing lesions involving the optic nerves (involving three or more segments of the optic nerve), and/or involving the optic chiasm, and optic tracts - Patients with a 25(OH)D > 80 nmol/L |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre, University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Conversion to clinically definite MS (CDMS) | Proportion of patients with clinically isolated syndromes (CIS) who convert to CDMS between groups | 12 months | |
Other | New T2 brain lesions on MRI | Mean number of new T2 lesions over study between groups | 12 months | |
Other | New contrast enhancing brain lesions on MRI | Mean number of new contrast enhancing lesions over study between groups | 12 months | |
Other | Exploratory novel MRI outcomes - diffusion tensor imaging (DTI) | Changes in optic nerve, tract and radiations DTI between groups over study | 12 months | |
Other | Exploratory novel MRI outcomes - texture | Changes in optic nerve, tract and radiations texture between groups over study | 12 months | |
Other | Exploratory novel MRI outcomes - cross-sectional area | Changes in optic nerve, tract and radiations cross-sectional area between groups over study | 12 months | |
Other | Thalamic volume on MRI | Mean thalamic volume over study between groups | 12 months | |
Primary | Inter-eye (IED) ganglion cell layer thickness (GCL) | The difference between the unaffected and affected eye GCL thickness between treatment and placebo group | month 12 | |
Primary | Proportion of patients with GCL IED <= 8 microns | The proportion of patients with unaffected and affected eye GCL thickness of < = 8 microns between groups | 12 months | |
Secondary | Change in mean GCL in affected eye over time | Rate of change in mean GCL thickness in affected eye over study between groups | baseline to 12 months | |
Secondary | Change in mean GCL in affected eye over time | Rate of change in mean GCL thickness in affected eye over study by 25(OH)D level | baseline to 12 months | |
Secondary | Change in mean GCL IED between eyes over time | Rate of change in mean GCL IED thickness in affected eye over study between groups | baseline to 12 months | |
Secondary | Change in mean GCL IED between eyes over time | Rate of change in mean GCL IED thickness in affected eye over study by 25(OH)D level | baseline to 12 months | |
Secondary | Change in mean retinal nerve fiber layer (RNFL) in affected eye over time | Rate of change in mean RNFL thickness in affected eye over study between groups | baseline to 12 months | |
Secondary | Change in mean RNFL in affected eye over time | Rate of change in mean RNFL thickness in affected eye over study by 25(OH)D level | baseline to 12 months | |
Secondary | Change in mean RNFL IED between eyes over time | Rate of change in mean RNFL and GCL thickness in affected eye over study between groups | baseline to 12 months | |
Secondary | Change in mean RNFL IED between eyes over time | Rate of change in mean RNFL and GCL thickness in affected eye over study by 25(OH)D level | baseline to 12 months | |
Secondary | Mean RNFL thickness | Mean RNFL thickness at baseline and months between groups | baseline | |
Secondary | Mean RNFL thickness | Mean RNFL thickness at month 1 between groups | 1 month | |
Secondary | Mean RNFL thickness | Mean RNFL thickness at month 6 between groups | 6 months | |
Secondary | Mean RNFL thickness | Mean RNFL thickness at month 12 between groups | 12 months | |
Secondary | Mean GCL thickness | Mean GCL thickness at baseline between groups | baseline to 12 months | |
Secondary | Mean GCL thickness | Mean GCL thickness at month 1 between groups | 1 month | |
Secondary | Mean GCL thickness | Mean GCL thickness at month 6 between groups | 6 months | |
Secondary | Mean GCL thickness | Mean GCL thickness at month 12 between groups | 12 months | |
Secondary | Inter-eye RNFL thickness | The difference between the unaffected and affected eye RNFL thickness at baseline between treatment and placebo groups | baseline to 12 months | |
Secondary | Inter-eye RNFL thickness | The difference between the unaffected and affected eye RNFL thickness at month 1 between treatment and placebo groups | 1 months | |
Secondary | Inter-eye RNFL thickness | The difference between the unaffected and affected eye RNFL thickness at month 6 between treatment and placebo groups | 6 months | |
Secondary | Inter-eye RNFL thickness | The difference between the unaffected and affected eye RNFL thickness at month 12 between treatment and placebo groups | 12 months | |
Secondary | Inter-eye GCL thickness | The difference between the unaffected and affected eye GCL thickness at baseline between treatment and placebo groups | baseline | |
Secondary | Inter-eye GCL thickness | The difference between the unaffected and affected eye GCL thickness at month 1 between treatment and placebo groups | 1 month | |
Secondary | Inter-eye GCL thickness | The difference between the unaffected and affected eye GCL thickness at month 6 between treatment and placebo groups | 6 months | |
Secondary | Inter-eye GCL thickness | The difference between the unaffected and affected eye RNFL thickness between treatment and placebo groups | 12 months | |
Secondary | Mean macular volume (MV) | Mean MV at baseline between groups | baseline | |
Secondary | Mean macular volume (MV) | Mean MV at month 1 between groups | 1 month | |
Secondary | Mean macular volume (MV) | Mean MV at month 6 between groups | 6 months | |
Secondary | Mean macular volume (MV) | Mean MV at month 12 between groups | 12 months | |
Secondary | Mean multifocal VEP (MfVEP) latency | Mean MfVEP at month 1 between groups | 1 month | |
Secondary | Mean change high and low contrast visual acuity (LogMAR) | Mean high and low contrast visual acuity (LogMAR) between groups at from baseline to month 12 | 12 months | |
Secondary | Correlation between baseline mean multifocal VEP latency and month-12 GCL, GCL inter-eye difference, RNFL and inter-eye RNFL difference between treatment and placebo groups | Correlation coefficient calculation between mean multifocal VEP latency at baseline and mean GCL, GCL inter-eye difference and RNFL and inter-eye RNFL difference at month 12 between treatment and placebo groups | 12 months |
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