NL-OMON45180已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- relapsing remitting multiple sclerosis (revised McDonald criteria 2005)
- •- 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)).
排除标准
- •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.
研究者
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