High-Dose Vitamin D Induction in Optic Neuritis

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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