Regulation of the stress-axis by vitamin D3 in subjects with multiple sclerosis; a double-blinded, randomized, placebo-controlled study
- Conditions
- Multiple SclerosisMS1000381610012303
- Registration Number
- NL-OMON45180
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
- relapsing remitting multiple sclerosis (revised McDonald criteria 2005)
- female
- age >18 years
- premenopausal
- At start of study > 6 weeks in clinical remission of disease
- use of no immune-modulating treatments or the currently registered firstline immune modulating therapies (including Interferon-beta (1a or 1b), glatiramer acetate, dimethylfumarate, teriflunomide) or second-line immune modulating therapies (incl. fingolimod (Gilenya) and natalizumab (Tysabri)).
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>We assess primarily the effect of vitamin D3 supplementation with a dose of<br /><br>4000 IU/day (100µg/ day) for 16 weeks on the cortisol day curve.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Furthermore, we assess the effect of the intervention on the slope of the<br /><br>cortisol day curve, a dexamethason suppression test, the cortisone awakening<br /><br>response, the CD4+ T cell cytokine profile and the HADS depression/ FSSS<br /><br>fatigue score, and we assess descriptively to which extent vitamin D levels in<br /><br>the serum are elevated, and assess whether the participant experience<br /><br>side-effects.</p><br>