Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02096133
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02096133
Study Brief:
Protocol Section:
NCT02096133