High-Dose Vitamin D Induction in Optic Neuritis

Phase

Condition

Vision Loss

Eye Disorders/infections

Treatment

Placebo/Standard of Care Vitamin D3

Vitamin D3

Clinical Study ID

NCT03302585

REB17-0922

Ages 18-45
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 McDonaldcriteria)
Patients must have an EDSS of 5.5 or less
Patients must demonstrate features of a first typical optic neuritis within 21 daysof recruitment (or must initiate treatment by day 30)
Patients must have a baseline 25(OH)D < 80 nmol/L regardless of vitamin D3supplementation
Patients must have no contraindications to high-dose vitamin D supplementation
Female patients must consent to use a reliable form of contraception (oralcontraceptive pill, intrauterine device, barrier methods, abstinence) for theduration of the active treatment phase (first 90 days of where study drug provided)of the trial
Patients must provide written informed consent.

Exclusion

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 involvingthe optic nerves (involving three or more segments of the optic nerve), and/orinvolving the optic chiasm, and optic tracts
Patients with a 25(OH)D > 80 nmol/L

Study Design

Placebo/Standard of Care Vitamin D3

November 23, 2017

May 09, 2024

Study Description

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.

Connect with a study center

Foothills Medical Centre, University of Calgary
Calgary, Alberta T2N 2T9
Canada
Site Not Available

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