Primary objective:- To determine whether high dose vitamin D treatment in optic neuritis can reduce axonal loss as measured by OCT. Secondary objectives: - To investigate whether the occurrence of a second attack (defining clinically definite MS) is…
ID
Source
Brief title
Condition
- Eye disorders NEC
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is retinal nerve fiber layer thickness in ON
patients with either vitamin D treatment of placebo, as measured by OCT.
Secondary outcome
Secondary endpoints include effects of vitamin D on occurrence of second
attack, visual outcome, clinical outcome and markers of immunology and
neurodegeneration in blood and cerebrospinal fluid.
Background summary
There is accumulating evidence for a possible protective role of vitamin D in
the development and disease course of multiple sclerosis (MS). Vitamin D is
cheap, easy to administer, and safe. However, intervention studies are few.
The first presenting symptom of MS is often optic neuritis (ON). Studies in MS
and ON patients show a decrease in retinal nerve fiber layer (RNFL) thickness
and macular volume, occurring within 1-3 months after ON. RNFL thickness can
accurately be measured using optical coherence tomography (OCT): a novel and
robust diagnostic tool. The rapid changes in RNFL after acute ON make it ideal
for testing neuroprotective strategies over a short time frame. Other
advantages of using ON patients to study the effect of vitamin D treatment
include the possibility of starting early in the pathology, a relatively large
availability of eligible patients because of the infrastructure and experience
of our MS center, and a well-defined symptom-onset, making it a relatively
homogenous group.
Study objective
Primary objective:
- To determine whether high dose vitamin D treatment in optic neuritis can
reduce axonal loss as measured by OCT.
Secondary objectives:
- 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.
Study design
Double-blind randomized placebo controlled trial
Intervention
Patients with unilateral optic neuritis will be randomly assigned to receive
either vitamin D (28.000 IU/week) or placebo. Follow-up will be 2 years.
Study burden and risks
Participants will undergo clinical assessment at five standardized time points.
Visual testing will be at four time points and OCT at three time points. Blood
samples will be collected every three months for trial and safety purposes. CSF
will be used for trial purposes; one extra spinal tap is required. Participants
will be asked to fill out questionnaires at 4 time points. Vitamin D will be
administered in a dosage of 28.000 IU/week, which is a safe dose according to
the European consensus criteria.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-018498-39-NL |
| CCMO | NL31899.078.10 |
| OMON | NL-OMON26942 |