High-Dose Vitamin D Induction in Optic Neuritis
A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2)
What it found
The trial ended early for another reason (see below).
Reason given: inability to meet recruitment goals
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
Placebo
- Placebo/Standard of Care Vitamin D3
What it measured
Main measures
Inter-eye (IED) ganglion cell layer thickness (GCL)
month 12
Retina scans (OCT)Proportion of patients with GCL IED <= 8 microns
12 months
Other measures (28)
Change in mean GCL in affected eye over time
baseline to 12 months
Change in mean GCL IED between eyes over time
baseline to 12 months
Change in mean retinal nerve fiber layer (RNFL) in affected eye over time
baseline to 12 months
Retina scans (OCT)Change in mean RNFL in affected eye over time
baseline to 12 months
Retina scans (OCT)Change in mean RNFL IED between eyes over time
baseline to 12 months
Retina scans (OCT)Mean RNFL thickness
baseline
Retina scans (OCT)Mean RNFL thickness
1 month
Retina scans (OCT)Mean RNFL thickness
6 months
Retina scans (OCT)Mean RNFL thickness
12 months
Retina scans (OCT)Mean GCL thickness
baseline to 12 months
Who could take part
Optic neuritis · 18 to 45
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Nov 2017
Main results due
May 2024
Finished
May 2024