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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2301 |
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Date of registration:
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19/04/2010 |
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Primary sponsor: |
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Public title:
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Vitamin D treatment effect on retinal nerve fiber loss after optic neuritis.
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Scientific title:
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Vitamin D treatment effect on retinal nerve fiber loss after optic neuritis. - VIDEO-trial |
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Date of first enrolment:
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1/7/2010 |
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Target sample size:
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120 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2301 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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T.
Runia |
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Address:
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Postbus 2040, Erasmus MC, faculteit, kamer Ee2230
3000 CA
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 7043980 |
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Email:
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t.runia@erasmusmc.nl |
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Affiliation:
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Name:
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T.
Runia |
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Address:
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Postbus 2040, Erasmus MC, faculteit, kamer Ee2230
3000 CA
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 7043980 |
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Email:
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t.runia@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Multiple sclerosis (MS), Vitamin D, Optic neuritis, Optical coherence tomography
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Intervention(s)
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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 administered once a week for 2 years.
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Primary Outcome(s)
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Retinal nerve fiber layer thickness, as measured by OCT at 6 months, 1 year and 2 years.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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NL31899.078.10 / 2010-018498-39 ;
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Source(s) of Monetary Support
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Dutch MS Research Foundation
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