Vitamin D3 and the Stress-axis in MS

NCT02096133 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-01-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Cholecalciferol

Vitamin D3 solution

OTHER

Placebo comparator

Placebo comparator

Sponsors & Collaborators

  • Academic MS Center Limburg

    lead OTHER

Principal Investigators

  • Raymond Hupperts, MD, PhD · Academic MS Center Limburg, Orbis MC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-13
Primary Completion
2016-11-07
Completion
2016-11-07

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096133 on ClinicalTrials.gov