NCT02096133

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2 multiple-sclerosis

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

October 13, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2016

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

March 21, 2014

Last Update Submit

January 24, 2017

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, vitamin D, HPA-axis, cortisol

Outcome Measures

Primary Outcomes (1)

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

    This number is constructed by combining the saliva cortisol levels at awakening, 11:00, 15:00, 20:00, and 22:00 hours (5 time-points).

    At baseline and after 16 weeks of supplementation.

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (2)

Cholecalciferol

EXPERIMENTAL

Patients receive 1dd 100ug vitamin D3 (drops) for 16 weeks

Drug: Cholecalciferol

Placebo comparator

PLACEBO COMPARATOR

placebo drops during 16 weeks

Other: Placebo comparator

Interventions

CholecalciferolDRUG

Vitamin D3 solution

Also known as: Vigantol Oil
Cholecalciferol
Placebo comparatorOTHER

Placebo comparator

Placebo comparator

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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®).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Academic MS Center Limburg, Orbis Medical Center

Sittard-Geleen, 6162 BG, Netherlands

Location

Related Publications (1)

  • Rolf L, Damoiseaux J, Huitinga I, Kimenai D, van den Ouweland J, Hupperts R, Smolders J. Stress-Axis Regulation by Vitamin D3 in Multiple Sclerosis. Front Neurol. 2018 Apr 26;9:263. doi: 10.3389/fneur.2018.00263. eCollection 2018.

    PMID: 29755397DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Raymond Hupperts, MD, PhD

    Academic MS Center Limburg, Orbis MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. R.M.M. Hupperts, MD, PhD, neurologist

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 26, 2014

Study Start

October 13, 2014

Primary Completion

November 7, 2016

Study Completion

November 7, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

NL(2)