Status:
TERMINATED
High-Dose Vitamin D Induction in Optic Neuritis
Lead Sponsor:
University of Calgary
Conditions:
Optic Neuritis
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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 re...
Detailed 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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03302585
Start Date
November 23 2017
End Date
May 9 2024
Last Update
July 24 2024
Active Locations (1)
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1
Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada, T2N 2T9