High-Dose Vitamin D Induction in Optic Neuritis
Key facts
- Who runs it
- University of Calgary
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 12 people enrolled
- Started
- 23 Nov 2017
- Ended
- 9 May 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Vitamin D3
- Placebo/Standard of Care Vitamin D3
- Record updated
- 24 July 2024
- Why it stopped
- inability to meet recruitment goals
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients who have had a previous optic neuritis
- 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 evidence of a non-inflammatory cause of optic neuropathy
- Patients with a 25(OH)D > 80 nmol/L
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- High-Dose Vitamin D Treatment GroupTreatment being tested
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)
Treatment: Vitamin D3
- Placebo/Standard Vitamin D3 GroupPlacebo, for comparison
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: Placebo/Standard of Care Vitamin D3
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2)
- Record updated
- 24 July 2024