High-Dose Vitamin D Induction in Optic Neuritis (VitaDON2)

July 22, 2024 updated by: Jodie Burton MD, MSc, FRCPC, University of Calgary

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre, University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-Dose Vitamin D Treatment Group

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
50,000 IU/d of oral vitamin D3 x 5 days followed by 10,000 IU/d of oral vitamin D3 x 85 days
Other Names:
  • Vitamin D - CHOLECALCIFEROL
Placebo Comparator: Placebo/Standard Vitamin D3 Group

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
50,000 IU/d of oral vitamin D3 x 5 days followed by 40,000 IU/d of oral vitamin D3 x 85 days
Other Names:
  • Vitamin D - CHOLECALCIFEROL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
month 12
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in mean GCL in affected eye over time
Time Frame: baseline to 12 months
Rate of change in mean GCL thickness in affected eye over study between groups
baseline to 12 months
Change in mean GCL in affected eye over time
Time Frame: baseline to 12 months
Rate of change in mean GCL thickness in affected eye over study by 25(OH)D level
baseline to 12 months
Change in mean GCL IED between eyes over time
Time Frame: baseline to 12 months
Rate of change in mean GCL IED thickness in affected eye over study between groups
baseline to 12 months
Change in mean GCL IED between eyes over time
Time Frame: baseline to 12 months
Rate of change in mean GCL IED thickness in affected eye over study by 25(OH)D level
baseline to 12 months
Change in mean retinal nerve fiber layer (RNFL) in affected eye over time
Time Frame: baseline to 12 months
Rate of change in mean RNFL thickness in affected eye over study between groups
baseline to 12 months
Change in mean RNFL in affected eye over time
Time Frame: baseline to 12 months
Rate of change in mean RNFL thickness in affected eye over study by 25(OH)D level
baseline to 12 months
Change in mean RNFL IED between eyes over time
Time Frame: baseline to 12 months
Rate of change in mean RNFL and GCL thickness in affected eye over study between groups
baseline to 12 months
Change in mean RNFL IED between eyes over time
Time Frame: baseline to 12 months
Rate of change in mean RNFL and GCL thickness in affected eye over study by 25(OH)D level
baseline to 12 months
Mean RNFL thickness
Time Frame: baseline
Mean RNFL thickness at baseline and months between groups
baseline
Mean RNFL thickness
Time Frame: 1 month
Mean RNFL thickness at month 1 between groups
1 month
Mean RNFL thickness
Time Frame: 6 months
Mean RNFL thickness at month 6 between groups
6 months
Mean RNFL thickness
Time Frame: 12 months
Mean RNFL thickness at month 12 between groups
12 months
Mean GCL thickness
Time Frame: baseline to 12 months
Mean GCL thickness at baseline between groups
baseline to 12 months
Mean GCL thickness
Time Frame: 1 month
Mean GCL thickness at month 1 between groups
1 month
Mean GCL thickness
Time Frame: 6 months
Mean GCL thickness at month 6 between groups
6 months
Mean GCL thickness
Time Frame: 12 months
Mean GCL thickness at month 12 between groups
12 months
Inter-eye RNFL thickness
Time Frame: baseline to 12 months
The difference between the unaffected and affected eye RNFL thickness at baseline between treatment and placebo groups
baseline to 12 months
Inter-eye RNFL thickness
Time Frame: 1 months
The difference between the unaffected and affected eye RNFL thickness at month 1 between treatment and placebo groups
1 months
Inter-eye RNFL thickness
Time Frame: 6 months
The difference between the unaffected and affected eye RNFL thickness at month 6 between treatment and placebo groups
6 months
Inter-eye RNFL thickness
Time Frame: 12 months
The difference between the unaffected and affected eye RNFL thickness at month 12 between treatment and placebo groups
12 months
Inter-eye GCL thickness
Time Frame: baseline
The difference between the unaffected and affected eye GCL thickness at baseline between treatment and placebo groups
baseline
Inter-eye GCL thickness
Time Frame: 1 month
The difference between the unaffected and affected eye GCL thickness at month 1 between treatment and placebo groups
1 month
Inter-eye GCL thickness
Time Frame: 6 months
The difference between the unaffected and affected eye GCL thickness at month 6 between treatment and placebo groups
6 months
Inter-eye GCL thickness
Time Frame: 12 months
The difference between the unaffected and affected eye RNFL thickness between treatment and placebo groups
12 months
Mean macular volume (MV)
Time Frame: baseline
Mean MV at baseline between groups
baseline
Mean macular volume (MV)
Time Frame: 1 month
Mean MV at month 1 between groups
1 month
Mean macular volume (MV)
Time Frame: 6 months
Mean MV at month 6 between groups
6 months
Mean macular volume (MV)
Time Frame: 12 months
Mean MV at month 12 between groups
12 months
Mean multifocal VEP (MfVEP) latency
Time Frame: 1 month
Mean MfVEP at month 1 between groups
1 month
Mean change high and low contrast visual acuity (LogMAR)
Time Frame: 12 months
Mean high and low contrast visual acuity (LogMAR) between groups at from baseline to month 12
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
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
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Conversion to clinically definite MS (CDMS)
Time Frame: 12 months
Proportion of patients with clinically isolated syndromes (CIS) who convert to CDMS between groups
12 months
New T2 brain lesions on MRI
Time Frame: 12 months
Mean number of new T2 lesions over study between groups
12 months
New contrast enhancing brain lesions on MRI
Time Frame: 12 months
Mean number of new contrast enhancing lesions over study between groups
12 months
Exploratory novel MRI outcomes - diffusion tensor imaging (DTI)
Time Frame: 12 months
Changes in optic nerve, tract and radiations DTI between groups over study
12 months
Exploratory novel MRI outcomes - texture
Time Frame: 12 months
Changes in optic nerve, tract and radiations texture between groups over study
12 months
Exploratory novel MRI outcomes - cross-sectional area
Time Frame: 12 months
Changes in optic nerve, tract and radiations cross-sectional area between groups over study
12 months
Thalamic volume on MRI
Time Frame: 12 months
Mean thalamic volume over study between groups
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jodie Burton, MD, MSc, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB17-0922

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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