High-Dose Vitamin D Induction in Optic Neuritis

NCT03302585 | Terminated Phase 2

• 1 other identifier: REB17-0922
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Optic Neuritis

Keywords

Optic Neuritis; Vitamin D

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (31)

• Change in mean GCL in affected eye over time

  baseline to 12 months

• 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 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

Other Outcomes (7)

• Conversion to clinically definite MS (CDMS)

  12 months

• New T2 brain lesions on MRI

  12 months

• New contrast enhancing brain lesions on MRI

  12 months

Study Arms (2)

High-Dose Vitamin D Treatment Group

EXPERIMENTAL

Patients in this arm will receive: -5 days of high-dose oral vitamin D3 (50,000 IU daily x 5), followed by 85 days of moderate dose oral vitamin D3 (10,000 IU daily x 85 days)

Drug: Vitamin D3

Placebo/Standard Vitamin D3 Group

PLACEBO COMPARATOR

Patients in this arm will receive Placebo/Standard of Care Vitamin D3: -5 days of placebo, followed by 85 days of standard of care dose of oral vitamin D3 (4,000 IU daily x 85 days)

Drug: Placebo/Standard of Care Vitamin D3

Interventions

Vitamin D3 DRUG

50,000 IU/d of oral vitamin D3 x 5 days followed by 10,000 IU/d of oral vitamin D3 x 85 days

Also known as: Vitamin D - CHOLECALCIFEROL

High-Dose Vitamin D Treatment Group

Placebo/Standard of Care Vitamin D3 DRUG

50,000 IU/d of oral vitamin D3 x 5 days followed by 40,000 IU/d of oral vitamin D3 x 85 days

Also known as: Vitamin D - CHOLECALCIFEROL

Placebo/Standard Vitamin D3 Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Optic Neuritis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jodie Burton, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masked randomization and allocation, only data safety monitor will know allocation if adverse event requires unblinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A double-blind randomized placebo/standard therapy phase II trial

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 5, 2017
• Study Start: November 23, 2017
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)