Optic NeuritisPhase 2VitaDON2NCT03302585
High-Dose Vitamin D Induction in Optic Neuritis
A Phase 2 study testing Vitamin D3 in people with Optic Neuritis, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2017to 9 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Foothills Medical Centre, University of Calgary
Calgary, Alberta, T2N 2T9
About this study
Official title: A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2)
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.
Read the 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 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.
- Conditions
- Optic Neuritis
- Being tested
- Vitamin D3, Placebo/Standard of Care Vitamin D3
- Keywords
- Optic Neuritis, Vitamin D
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Vitamin D - CHOLECALCIFEROL
50,000 IU/d of oral vitamin D3 x 5 days followed by 10,000 IU/d of oral vitamin D3 x 85 days
Placebo/Standard of Care Vitamin D3Drug
Also called Vitamin D - CHOLECALCIFEROL
50,000 IU/d of oral vitamin D3 x 5 days followed by 40,000 IU/d of oral vitamin D3 x 85 days
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Placebo/Standard of Care Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-eye (IED) ganglion cell layer thickness (GCL)
The difference between the unaffected and affected eye GCL thickness between treatment and placebo group
Measured: 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
Measured: 12 months
Secondary outcomes (31)
Change in mean GCL in affected eye over time
Rate of change in mean GCL thickness in affected eye over study between groups
Measured: baseline to 12 months
Change in mean GCL in affected eye over time
Rate of change in mean GCL thickness in affected eye over study by 25(OH)D level
Measured: baseline to 12 months
Change in mean GCL IED between eyes over time
Rate of change in mean GCL IED thickness in affected eye over study between groups
Measured: baseline to 12 months
Change in mean GCL IED between eyes over time
Rate of change in mean GCL IED thickness in affected eye over study by 25(OH)D level
Measured: baseline to 12 months
Change in mean retinal nerve fiber layer (RNFL) in affected eye over time
Rate of change in mean RNFL thickness in affected eye over study between groups
Measured: baseline to 12 months
Change in mean RNFL in affected eye over time
Rate of change in mean RNFL thickness in affected eye over study by 25(OH)D level
Measured: baseline to 12 months
Change in mean RNFL IED between eyes over time
Rate of change in mean RNFL and GCL thickness in affected eye over study between groups
Measured: baseline to 12 months
Change in mean RNFL IED between eyes over time
Rate of change in mean RNFL and GCL thickness in affected eye over study by 25(OH)D level
Measured: baseline to 12 months
Mean RNFL thickness
Mean RNFL thickness at baseline and months between groups
Measured: baseline
Mean RNFL thickness
Mean RNFL thickness at month 1 between groups
Measured: 1 month
Mean RNFL thickness
Mean RNFL thickness at month 6 between groups
Measured: 6 months
Mean RNFL thickness
Mean RNFL thickness at month 12 between groups
Measured: 12 months
Mean GCL thickness
Mean GCL thickness at baseline between groups
Measured: baseline to 12 months
Mean GCL thickness
Mean GCL thickness at month 1 between groups
Measured: 1 month
Mean GCL thickness
Mean GCL thickness at month 6 between groups
Measured: 6 months
Mean GCL thickness
Mean GCL thickness at month 12 between groups
Measured: 12 months
Inter-eye RNFL thickness
The difference between the unaffected and affected eye RNFL thickness at baseline between treatment and placebo groups
Measured: baseline to 12 months
Inter-eye RNFL thickness
The difference between the unaffected and affected eye RNFL thickness at month 1 between treatment and placebo groups
Measured: 1 months
Inter-eye RNFL thickness
The difference between the unaffected and affected eye RNFL thickness at month 6 between treatment and placebo groups
Measured: 6 months
Inter-eye RNFL thickness
The difference between the unaffected and affected eye RNFL thickness at month 12 between treatment and placebo groups
Measured: 12 months
Inter-eye GCL thickness
The difference between the unaffected and affected eye GCL thickness at baseline between treatment and placebo groups
Measured: baseline
Inter-eye GCL thickness
The difference between the unaffected and affected eye GCL thickness at month 1 between treatment and placebo groups
Measured: 1 month
Inter-eye GCL thickness
The difference between the unaffected and affected eye GCL thickness at month 6 between treatment and placebo groups
Measured: 6 months
Inter-eye GCL thickness
The difference between the unaffected and affected eye RNFL thickness between treatment and placebo groups
Measured: 12 months
Mean macular volume (MV)
Mean MV at baseline between groups
Measured: baseline
Mean macular volume (MV)
Mean MV at month 1 between groups
Measured: 1 month
Mean macular volume (MV)
Mean MV at month 6 between groups
Measured: 6 months
Mean macular volume (MV)
Mean MV at month 12 between groups
Measured: 12 months
Mean multifocal VEP (MfVEP) latency
Mean MfVEP at month 1 between groups
Measured: 1 month
Mean change high and low contrast visual acuity (LogMAR)
Mean high and low contrast visual acuity (LogMAR) between groups at from baseline to month 12
Measured: 12 months
Correlation between baseline mean multifocal VEP latency and month-12 GCL, GCL inter-eye difference, RNFL and inter-eye RNFL difference between treatment and placebo groups
Correlation coefficient calculation between mean multifocal VEP latency at baseline and mean GCL, GCL inter-eye difference and RNFL and inter-eye RNFL difference at month 12 between treatment and placebo groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start23 Nov 2017
- Primary completion9 May 2024
- Study completion9 May 2024
Why it stopped: inability to meet recruitment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind randomized placebo/standard therapy phase II trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jodie Burton MD, MSc, FRCPC, University of Calgary
- Investigators
- Jodie Burton, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302585
- Sponsor's protocol ID
- REB17-0922
- Acronym
- VitaDON2
- Status last verified
- Jul 2024
- First submitted
- 27 Sep 2017
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2)
- ClinicalTrials.gov ID
- NCT03302585
- Acronym / sponsor ID
- VitaDON2 / REB17-0922
- Conditions
- Optic Neuritis
- Keywords
- Optic Neuritis, Vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to meet recruitment goals
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind randomized placebo/standard therapy phase II trial
| Arm | Type | Receives |
|---|---|---|
| High-Dose Vitamin D Treatment Group | Experimental | Drug: Vitamin D3Patients 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) |
| Placebo/Standard Vitamin D3 Group | Placebo comparator | Drug: Placebo/Standard of Care Vitamin D3Patients 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: Vitamin D - CHOLECALCIFEROL50,000 IU/d of oral vitamin D3 x 5 days followed by 10,000 IU/d of oral vitamin D3 x 85 days | Drug | High-Dose Vitamin D Treatment Group |
| Placebo/Standard of Care Vitamin D3Also: Vitamin D - CHOLECALCIFEROL50,000 IU/d of oral vitamin D3 x 5 days followed by 40,000 IU/d of oral vitamin D3 x 85 days | Drug | Placebo/Standard Vitamin D3 Group |
Primary outcome
Inter-eye (IED) ganglion cell layer thickness (GCL)
Time frame: month 12
The difference between the unaffected and affected eye GCL thickness between treatment and placebo group
Proportion of patients with GCL IED <= 8 microns
Time frame: 12 months
The proportion of patients with unaffected and affected eye GCL thickness of < = 8 microns between groups
31 secondary outcomes
Change in mean GCL in affected eye over time
Time frame: baseline to 12 months
Change in mean GCL in affected eye over time
Time frame: baseline to 12 months
Change in mean GCL IED between eyes over time
Time frame: baseline to 12 months
Change in mean GCL IED between eyes over time
Time frame: baseline to 12 months
Change in mean retinal nerve fiber layer (RNFL) in affected eye over time
Time frame: baseline to 12 months
Change in mean RNFL in affected eye over time
Time frame: baseline to 12 months
Change in mean RNFL IED between eyes over time
Time frame: baseline to 12 months
Change in mean RNFL IED between eyes over time
Time frame: baseline to 12 months
Mean RNFL thickness
Time frame: baseline
Mean RNFL thickness
Time frame: 1 month
Mean RNFL thickness
Time frame: 6 months
Mean RNFL thickness
Time frame: 12 months
Mean GCL thickness
Time frame: baseline to 12 months
Mean GCL thickness
Time frame: 1 month
Mean GCL thickness
Time frame: 6 months
Mean GCL thickness
Time frame: 12 months
Inter-eye RNFL thickness
Time frame: baseline to 12 months
Inter-eye RNFL thickness
Time frame: 1 months
Inter-eye RNFL thickness
Time frame: 6 months
Inter-eye RNFL thickness
Time frame: 12 months
Inter-eye GCL thickness
Time frame: baseline
Inter-eye GCL thickness
Time frame: 1 month
Inter-eye GCL thickness
Time frame: 6 months
Inter-eye GCL thickness
Time frame: 12 months
Mean macular volume (MV)
Time frame: baseline
Mean macular volume (MV)
Time frame: 1 month
Mean macular volume (MV)
Time frame: 6 months
Mean macular volume (MV)
Time frame: 12 months
Mean multifocal VEP (MfVEP) latency
Time frame: 1 month
Mean change high and low contrast visual acuity (LogMAR)
Time frame: 12 months
Correlation between baseline mean multifocal VEP latency and month-12 GCL, GCL inter-eye difference, RNFL and inter-eye RNFL difference between treatment and placebo groups
Time frame: 12 months
Results and safety
The study was stopped early (reason given: inability to meet recruitment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodie Burton, MD, MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Optic Neuritis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: inability to meet recruitment goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-eye (IED) ganglion cell layer thickness (GCL) (time frame: month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.