NCT02096133

Vitamin D3 and the Stress-axis in MS

Terminated Phase 2 Last updated 25 January 2017

What this trial tests

Phase 2 trial testing Cholecalciferol in Multiple Sclerosis in 54 participants. Terminated before completion.

Timeline

13 October 2014

Primary endpoint
7 November 2016

7 November 2016

Quick facts

Lead sponsor	Academic MS Center Limburg
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	54
Start date	13 October 2014
Primary completion	7 November 2016
Estimated completion	7 November 2016
Sites	2 locations across Netherlands

Drugs / interventions tested

• Cholecalciferol (cholecalciferol) — full drug profile →
• Placebo comparator

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Academic MS Center Limburg

Who can join

18 and older, female only, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Stress-Axis Regulation by Vitamin D₃ in Multiple Sclerosis.
   Rolf L, Damoiseaux J, Huitinga I, Kimenai D, et al · · 2018 · cited 21× · PMID 29755397 · DOI 10.3389/fneur.2018.00263