Vitamin D3 and the Stress-axis in MS

Regulation of the Stress-axis by Vitamin D3 in Subjects With Multiple Sclerosis; a Double-blinded, Randomized, Placebo-controlled Study

Stopped earlyPhase 2Relapsing MSNCT020961332014-000728-97

What it found

Stopped

The trial ended early for another reason (see below).

16 weeks

Read by software from the paper's abstract

Reason given: difficulties with inclusion

What was tested

Treatment tested

  • Cholecalciferol

    Vitamin D receptor agonist

  • Vigantol® Oil

Placebo

  • Placebo comparator

What it measured

Main measures

  • The area under the curve (AUC) of the cortisol day curve

    At baseline and after 16 weeks of supplementation.

    How the body handles the medicine

Other measures (6)

  • The slope of the cortisol day-curve

    At baseline and after 16 weeks of supplementation

  • The cortisol awakening response

    At baseline and after 16 weeks of supplementation

  • Clinical outcomes on depression

    At baseline and after 16 weeks of supplementation

    FatigueMood and sleep

  • Efficacy of supplementation

    At baseline and after 16 weeks of supplementation. Side effects will also be checked at 8 weeks of supplementation.

  • Side effects

    At baseline, after 8 and after 16 weeks

    Safety

  • The slope of the cortisol day-curve and the cortisol awakening response.

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion criteria

* Female * Relapsing Remitting MS * At start of study > 6 weeks in clinical remission of disease * Age > 18 years. * Premenopausal * Treated with either no immune-modulating treatment, or the currently registered MS modulating treatments: Interferon beta 1a (Rebif®), Interferon Beta 1b (Betaferon® or Avonex®), Glatiramer Acetate (Copaxone®), dimethylfumarate (Tecfidera®), teriflunomide (Aubagio®)) or fingolimod (Gilenya®).

Exclusion criteria

* Any contraindication to vitamin D according to Summary of Product Characteristics: Hypercalcaemia, hypervitaminosis D, nephrolithiasis, diseases or conditions resulting in hypercalcaemia and/or hypercalciuria (incl. primary hyperparathyroidism), severe renal impairment . * Use of dexamethasone or other systemic glucocorticosteroids \<2 months prior to first study visit * Supplementation of >=1000 IU/d (25µg) vitamin D2 or D3 * Medical history of disturbed vitamin D/ calcium metabolism other than low intake * Present clinical (major)depression * Present treatment with anti-depressants, benzodiazepines, or neuroleptics. * Treatment with high-dose dexamethasone for MS exacerbation during study. * Pregnancy or the intention to become pregnant during the study period.

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

About this trial

In the sponsor's words

Patients with multiple sclerosis (MS) have an increased risk of developing a major depression. The investigators observed a protective effect of high vitamin D levels on the risk of depression in MS. This might be driven by the effect of vitamin D on the stress-axis. Therefore, the main goal of the present study is to assess whether high dose vitamin D supplementation results in a suppression of the stress-axis, as measured by decreased levels of cortisol.

Papers

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History

    1. Started

      Oct 2014

    2. Main results due

      Nov 2016

    3. Finished

      Nov 2016

    Assembled by software from public sources.