The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography

Status unknownPhase 2Optic neuritisNCT01465893

What it found

Missed its main goal

The main measure did not show a significant benefit.

“Average thickness of RNFL at the end of trial did not differ between groups.”
Read by software from the paper's abstract

changes in thickness of RNFL and macula 6 months after treatment · 6 months

GroupnValue
vitamin D27mean (SD) RNFL thickness decreased from 111.3 (18.9) μm at baseline to 91.4 (13.3) at end of study (P < 0.001)
placebo25mean (SD) RNFL thickness decreased from 113.7 (21.5) μm at baseline to 96.1 (12.3) at end of study (P < 0.01)

p = > 0.05 for macula thickness change; RNFL between-group difference not significant

Total participants: 52

Read by software from the paper's abstract

What was tested

Treatment tested

  • Ergocalciferol

    Vitamin D receptor agonist

Placebo

  • Vitamin D withheld

What it measured

Main measures

  • measurement Retinal nerve fiber layer (RNFL) thickness by OCT

    10-32 days after optic neuritis

    Retina scans (OCT)

Other measures (1)

  • measurement RNFL thickness by OCT

    6 months after optic neuritis

    Retina scans (OCT)

Who could take part

Optic neuritis · 15 to 50

Show the full criteria

Inclusion criteria

* age 15-50 years * no history of demyelinative events * level of vitamin d below 20 ng/ml * no pass 10-32 day from starting symptom

Exclusion criteria

* using vitamin D supplement

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study examines the effect of vitamin D on Retinal changes in patient with optic Neuritis.

Papers

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History

    1. Started

      Jul 2011

    2. Main results due

      Jul 2012

    3. Finished

      Dec 2012

    Assembled by software from public sources.