VItamin D treatment Effect on retinal nerve fiber loss after Optic neuritis - VIDEO-trial

• Conditions: Optic neuritis; MedDRA version: 12.1Level: LLTClassification code 10029247Term: Neuritis optic; MedDRA version: 12.1Level: LLTClassification code 10030946Term: Optic neuritis, unspecified; MedDRA version: 12.1Level: LLTClassification code 10030942Term: Optic neuritis

• Registration Number: EUCTR2010-018498-39-NL
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified