Regulation of the stress-axis by vitamin D in subjects with multiple sclerosis.

Phase 1

Conditions: Relapsing remitting multiple sclerosis
MedDRA version: 18.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-000728-97-NL

Lead Sponsor: Academic MS Center Limburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

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 currently registered first-line MS modulating treatments (including Interferon beta 1a (Rebif®) or Interferon Beta 1b (Betaferon® or Avonex®), Glatiramer Acetate (Copaxone®), dimethylfumarate (Tecfidera®) or teriflunomide (Aubagio®)) or registered second-line MS modulating treatments (incl. fingolimod(Gilenya®) or natalizumab (Tysabri®)).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any contraindication to vitamin D according to Summary of Product Characteristics
•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
•Treatment with high-dose dexamethason for MS exacerbation during study.
•Pregnancy or the intention to become pregnant during the study period.