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Vitamin D

Vitamin D3 for Optic Neuritis (VitaDON2 Trial)

Q: Are elderly patients above the age of eighty-five able to enroll in this clinical trial?

The age requirement for this study is that potential patients must be 18-45 years old.

Q: How many people can be a part of this research project?

Yes, the information on clinicaltrials.gov indicates that this trial is presently recruiting patients. The clinical trial was initially posted on 11/23/2017 and was last edited on 2/5/2019. The trial is searching for 66 patients across 1 sites.

Q: What is the precedent for using Vitamin D3 in medical trials?

As of now, there are 64 ongoing clinical trials for Vitamin D3 with 22 in the last stages. The majority of these tests are taking place in Dallas, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>; however, 210 research facilities across the globe are conducting investigations into this supplement.

Q: Who might this trial be most useful for?

This clinical trial is testing a new medication for optic neuritis in patients aged 18-45. To date, 66 individuals have been accepted into the study.

Q: What are the investigators of this study aiming to achieve?

This clinical trial will last for 12 months and aim to measure the proportion of patients with GCL IED &#x3C;= 8 microns. Additionally, the study will look at secondary outcomes including the correlation between baseline mean multifocal VEP latency and month-12 GCL, as well as the RNFL and inter-eye RNFL difference between treatment and placebo groups.

Q: Are participants still being sought for this research?

This clinical trial is recruiting patients, as stated on the website clinicaltrials.gov. The first posting was on 11/23/2017, and the most recent update was on 2/5/2019.

Q: What does the FDA have to say about Vitamin D3?

While Phase 2 trials are not as well-supported by data, our team believes that Vitamin D3 can be given a score of 2 in terms of safety.

Q: What is the main reason why doctors prescribe Vitamin D3?

Vitamin D3 is not only effective in calcium absorption, but it can also help to improve conditions such as post-menopausal bone density loss and the risk of fractures.

Phase 2

Waitlist Available

Led By Jodie Burton, MD, MSc

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

VitaDON2 Trial Summary

This trial is testing whether giving vitamin D to people with optic neuritis (damage to the eye nerve) soon after they develop the condition results in better visual outcomes at 12 months compared to those who do not receive the vitamin D.

Eligible Conditions

Optic Neuritis

VitaDON2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Inter-eye (IED) ganglion cell layer thickness (GCL)

Proportion of patients with GCL IED <= 8 microns

Secondary outcome measures

Change in mean GCL IED between eyes over time

Change in mean GCL in affected eye over time

Change in mean RNFL IED between eyes over time

+10 more

Other outcome measures

Conversion to clinically definite MS (CDMS)

Exploratory novel MRI outcomes - cross-sectional area

Exploratory novel MRI outcomes - diffusion tensor imaging (DTI)

+4 more

VitaDON2 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High-Dose Vitamin D Treatment GroupExperimental Treatment1 Intervention

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)

Group II: Placebo/Standard Vitamin D3 GroupPlacebo Group1 Intervention

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cholecalciferol

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

791 Previous Clinical Trials

868,668 Total Patients Enrolled

1 Trials studying Optic Neuritis

6 Patients Enrolled for Optic Neuritis

Jodie Burton, MD, MScPrincipal InvestigatorUniversity of Calgary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly patients above the age of eighty-five able to enroll in this clinical trial?

"The age requirement for this study is that potential patients must be 18-45 years old."

Answered by AI

How many people can be a part of this research project?

"Yes, the information on clinicaltrials.gov indicates that this trial is presently recruiting patients. The clinical trial was initially posted on 11/23/2017 and was last edited on 2/5/2019. The trial is searching for 66 patients across 1 sites."

Answered by AI

What is the precedent for using Vitamin D3 in medical trials?

"As of now, there are 64 ongoing clinical trials for Vitamin D3 with 22 in the last stages. The majority of these tests are taking place in Dallas, Texas; however, 210 research facilities across the globe are conducting investigations into this supplement."

Answered by AI

Who might this trial be most useful for?

"This clinical trial is testing a new medication for optic neuritis in patients aged 18-45. To date, 66 individuals have been accepted into the study."

Answered by AI

What are the investigators of this study aiming to achieve?

"This clinical trial will last for 12 months and aim to measure the proportion of patients with GCL IED <= 8 microns. Additionally, the study will look at secondary outcomes including the correlation between baseline mean multifocal VEP latency and month-12 GCL, as well as the RNFL and inter-eye RNFL difference between treatment and placebo groups."

Answered by AI

Are participants still being sought for this research?

"This clinical trial is recruiting patients, as stated on the website clinicaltrials.gov. The first posting was on 11/23/2017, and the most recent update was on 2/5/2019."

Answered by AI

What does the FDA have to say about Vitamin D3?

"While Phase 2 trials are not as well-supported by data, our team believes that Vitamin D3 can be given a score of 2 in terms of safety."

Answered by AI

What is the main reason why doctors prescribe Vitamin D3?

"Vitamin D3 is not only effective in calcium absorption, but it can also help to improve conditions such as post-menopausal bone density loss and the risk of fractures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High-Dose Vitamin D Induction in Optic Neuritis

Jodie Burton MD, MSc, FRCPC 2017. "High-Dose Vitamin D Induction in Optic Neuritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03302585.

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