Vitamin D treatment effect on retinal nerve fiber loss after optic neuritis

Phase 2

Recruiting

• Conditions: inflammation of the optic nerve; Optic neuritis; 10015917; 10003816; 10012303

• Registration Number: NL-OMON34666
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

- Single unilateral optic neuritis
- Age between 18 and 50 year
- Neuro-ophtalmological examination within 4 weeks of symptom onset

Exclusion Criteria

- Prior known optic neuritis, MS or prior symptoms suggestive of demyelination;
- Other suspected or established causes of vision loss (e.g. glaucoma, amblyopia);
- Inability to undergo OCT testing;
- Use of more than 1 vitamin supplement;
- Use of immunomodulatory therapy (e.g. interferone) in the 3 months prior to inclusion;
- Methylprednisolone treatment in the 3 months prior to inclusion;
- Renal failure (creatinine clearance of < 40 ml/min);
- Hypercalcemia;
- Sarcoidosis;
- Allergy to peanuts.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is retinal nerve fiber layer thickness in ON<br /><br>patients with either vitamin D treatment of placebo, as measured by OCT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include effects of vitamin D on occurrence of second<br /><br>attack, visual outcome, clinical outcome and markers of immunology and<br /><br>neurodegeneration in blood and cerebrospinal fluid. </p><br>