Regulation of the stress-axis by vitamin D3 in subjects with multiple sclerosis; a double-blinded, randomized, placebo-controlled study - Vitamin D3 and the stress-axis in MS

Academic MS Center Limburg0 个研究点开始时间: 2014年5月8日最近更新: 2017年2月20日

适应症

试验速览

暂无简介。

•-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

•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.

发起方

Academic MS Center Limburg