Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients

Status unknownPhase 4Relapsing MSNCT01417273

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Retinol

Placebo

  • Drug: placebo

What it measured

Main measures

  • Expanded Disability Status Scale (EDSS)

    Change from baseline at 12 months

    Disability progression
  • Multiple Sclerosis Functional Composite (MSFC)

    Change from baseline at 12 months

    Disability progression
  • fatigue scores

    Change from baseline at 12 months

    Fatigue
  • depression score

    Change from baseline at 12 months

    Mood and sleep
  • Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI

    Change from baseline at 12 months

    MRI lesions

Other measures (1)

  • number of disease relapses

    Change from baseline at 12 months

    Relapses

Who could take part

Relapsing MS · 20 to 45

Show the full criteria

Inclusion criteria

* Patients who have used interferon beta in last 3 months * Patients with 0-5 EDSS

Exclusion criteria

* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR * Patients who have allergy to vitamin A compounds, OR * Patients who have used vitamin supplements in last 3 months.

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

About this trial

In the sponsor's words

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for next 6 months on disease activity and progression in patients with Multiple Sclerosis.

Papers

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Related trials

History

    1. Started

      Feb 2010

    2. Main results due

      Feb 2013

    3. Finished

      Aug 2013

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