Optic neuritis MedDRA version: 12.1 Level: LLT Classification code 10029247 Term: Neuritis optic MedDRA version: 12.1 Level: LLT Classification code 10030946 Term: Optic neuritis, unspecified MedDRA version: 12.1 Level: LLT Classification code 10030942 Term: Optic neuritis
Conditions
Interventions
Product Name: Cholecalciferol
Product Code: Cholecalciferol
Pharmaceutical Form: Oral liquid
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: Colecalciferol
Other descript
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients fulfilling the following criteria are included: - Single unilateral optic neurits (ON) - Age between 18 and 50 year - Neuro-ophtalmological examination within 4 weeks of symptom onset Clinically confirmed ON is defined as fulfilling at least 4 of 5 of following criteria: pain with eye movement, sub-acute onset of decreased Snellen acuity, color vision loss, a relative afferent pupillary defect, and compatible fundus examination (i.e. mild or no optic edema and the absence of pallor at the time of the acute event). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients are excluded who: - Have prior known ON, MS or prior symptoms suggestive of demyelination; - Have other suspected or established causes of vision loss (e.g. glaucoma, amblyopia); - Are unable to undergo OCT testing; - Use more than 1 vitamin supplement; - Have used immunomodulatory therapy (e.g. interferone) in the 3 months prior to inclusion; - Have had methylprednisolone treatment in the 3 months prior to inclusion; - Have an allergy to peanuts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether high dose vitamin D treatment in optic neuritis can reduce axonal loss as measured by Optical Coherence Tomography (OCT);Secondary Objective: - To investigate whether the occurrence of a second attack (defining clinically definite MS) is postponed in the vitamin D treatment group compared to placebo; - To investigate the effect of vitamin D treatment on visual outcome measures (visual acuity and visual field); - To investigate the effect of vitamin D treatment on clinical outcome measures (EDSS, MSIS, fatigue scales); - To investigate the effect of vitamin D treatment on immune and neurodegenerative markers in blood and CSF.;Primary end point(s): The main endpoint of this study is retinal nerve fiber layer thickness in optic neuritis patients with either vitamin D treatment of placebo, as measured by OCT. | — |
Countries
Netherlands
Outcome results
None listed