Overview

Vitamin D3 and the Stress-axis in MS

Status:
Terminated
Trial end date:
2016-11-07
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Academic MS Center Limburg
Treatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
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 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®).

Exclusion Criteria:

- 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.