Vitamin D3 and the Stress-axis in MS

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02096133
• Date of registration: 21/03/2014
• Prospective Registration: Yes
• Primary sponsor: Academic MS Center Limburg
• Public title: Vitamin D3 and the Stress-axis in MS
• Scientific title: Regulation of the Stress-axis by Vitamin D3 in Subjects With Multiple Sclerosis; a Double-blinded, Randomized, Placebo-controlled Study
• Date of first enrolment: October 13, 2014
• Target sample size: 54
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02096133
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Raymond Hupperts, MD, PhD
• Affiliation: Academic MS Center Limburg, Orbis MC

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Other: Placebo comparator

Drug: Cholecalciferol

Primary Outcome(s)

The area under the curve (AUC) of the cortisol day curve [Time Frame: At baseline and after 16 weeks of supplementation.]

Secondary Outcome(s)

Clinical outcomes on depression [Time Frame: At baseline and after 16 weeks of supplementation]

Side effects [Time Frame: At baseline, after 8 and after 16 weeks]

The slope of the cortisol day-curve [Time Frame: At baseline and after 16 weeks of supplementation]

Efficacy of supplementation [Time Frame: At baseline and after 16 weeks of supplementation. Side effects will also be checked at 8 weeks of supplementation.]

The cortisol awakening response [Time Frame: At baseline and after 16 weeks of supplementation]

Secondary ID(s)

EMR200109_635

2014-000728-97

Source(s) of Monetary Support

Please refer to primary and secondary sponsors