Multiple sclerosis, MS, vitamin D, optic neuritis, optical coherence tomography, OCT. Vitamine D, neuritis optica.
Conditions
Interventions
Patients with unilateral optic neuritis will be randomly assigned to receive either vitamin D3 (Cholecalciferol) as an oral liquid medicine (14.000 IU/week) or placebo. Study medication will be admini
Sponsors
Erasmus Medical Center, Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Single unilateral ON; 2. Age between 18 and 50 year; 3. Neuro-ophtalmological examination within 4 weeks of symptom onset.
Exclusion criteria
Exclusion criteria: 1. Prior known ON, MS or prior symptoms suggestive of demyelination; 2. Other suspected or established causes of vision loss (e.g. glaucoma, amblyopia); 3. Inability to undergo OCT testing; 4. Use of more than 1 vitamin supplement; 5. Use of immunomodulatory therapy (e.g. interferone) in the 3 months prior to inclusion; 6. Methylprednisolone treatment in the 3 months prior to inclusion; 7. Allergy to peanuts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retinal nerve fiber layer thickness, as measured by OCT at 6 months, 1 year and 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to second attack; 2. Visual acuity and visual field at 6 months, 1 year and 2 years; 3. Clinical outcome measures (EDSS, MSIS, FSS, HADS) at 6 months, 1 year and 2 years; 4. T2 lesion load on brain MRI at 2 years; 5. Markers of immunology and neurodegeneration and T cell function at 6 months, 1 year and 2 years. | — |
Contacts
Public ContactT. Runia
Postbus 2040
Outcome results
None listed