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Vitamin D3 and the Stress-axis in MS

2017年1月24日 更新者:Raymond Hupperts、Academic MS Center Limburg

Regulation of the Stress-axis by Vitamin D3 in Subjects With Multiple Sclerosis; a Double-blinded, Randomized, Placebo-controlled Study

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.

研究概览

详细说明

The lifetime incidence of a major depression in Multiple Sclerosis (MS) is 50%. (Patten et al. Neurology 2003; 61(11):1524-7) Our group reported a negative correlation between vitamin D status and depression score of the Hospital Anxiety and Depression Scale (HADS) in a cross-sectional dataset of Dutch MS patients. (Knippenberg et al. Acta Neurol Scand 2011; 124(3):171-5) This suggests an interaction between vitamin D and biological mechanisms affecting susceptibility to depression. Currently, we have two main hypotheses: 1) Vitamin D regulates the hypothalamic stress axis in MS. Based on our findings that cortisol releasing hormone (CRH)-positive hypothalamic neurons in the brains of MS patients stained positive for the vitamin D receptor (VDR) and 1,25(OH)2D-24-hydroxylase (24-OHase). (smolders et al. J Neuropathol Exp Neurol 2013;72(2):91-105) 2) Vitamin D affects T cell cytokine profile and hereby the odds of developing depression. Also in non-MS depressed patients increased levels of pro-inflammatory cytokines are detected (Maes et al. Metab Brain Dis 2009; 24: 27-53). Vitamin D3 has shown to be a potent promotor of T cell regulation both in vitro and in vivo. (Smolders et al. J Neuroimmunol 2008;194:7-17 and Smolders et al. PLoS One 2010;5:e15235) The main goal of this study is to assess whether supplementation of high doses vitamin D3 results in a suppression of saliva cortisol day-curves in subjects with multiple sclerosis, and we will explore whether the pro-inflammatory cytokine profile of T lymphocytes is regulated.

研究类型

介入性

注册 (实际的)

54

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nijmegen、荷兰
        • Canisius Wilhelmina Ziekenhuis
      • Sittard-Geleen、荷兰、6162 BG
        • Academic MS Center Limburg, Orbis Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Cholecalciferol
Patients receive 1dd 100ug vitamin D3 (drops) for 16 weeks
Vitamin D3 solution
其他名称:
  • 维甘醇油
安慰剂比较:Placebo comparator
placebo drops during 16 weeks
安慰剂对照

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The area under the curve (AUC) of the cortisol day curve
大体时间:At baseline and after 16 weeks of supplementation.
This number is constructed by combining the saliva cortisol levels at awakening, 11:00, 15:00, 20:00, and 22:00 hours (5 time-points).
At baseline and after 16 weeks of supplementation.

次要结果测量

结果测量
措施说明
大体时间
The slope of the cortisol day-curve
大体时间:At baseline and after 16 weeks of supplementation
The slope of the day-curve is the slope of the decrease of saliva cortisol measured throughout the cortisol day curve
At baseline and after 16 weeks of supplementation
The cortisol awakening response
大体时间:At baseline and after 16 weeks of supplementation
The awakening response is described by the rise in saliva cortisol from awakening to 60 minutes after awakening with respectively measurements at awakening, 15 minutes, 30 minutes, 45 minutes and 60 minutes (5 time-points).
At baseline and after 16 weeks of supplementation
Clinical outcomes on depression
大体时间:At baseline and after 16 weeks of supplementation
The clinical outcomes on depression will be measured by the depression sub-score of HADS and the FSSS fatigue score.
At baseline and after 16 weeks of supplementation
Efficacy of supplementation
大体时间:At baseline and after 16 weeks of supplementation. Side effects will also be checked at 8 weeks of supplementation.
To measure efficacy 25(OH)D levels will be measured.
At baseline and after 16 weeks of supplementation. Side effects will also be checked at 8 weeks of supplementation.
Side effects
大体时间:At baseline, after 8 and after 16 weeks
Side effects will be measured after 8 and 16 weeks of treatment. Serum levels of calcium, albumin and creatinine will be determined, as well as calcium and creatinine levels in urine.
At baseline, after 8 and after 16 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Raymond Hupperts, MD, PhD、Academic MS Center Limburg, Orbis MC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年10月13日

初级完成 (实际的)

2016年11月7日

研究完成 (实际的)

2016年11月7日

研究注册日期

首次提交

2014年3月21日

首先提交符合 QC 标准的

2014年3月24日

首次发布 (估计)

2014年3月26日

研究记录更新

最后更新发布 (估计)

2017年1月25日

上次提交的符合 QC 标准的更新

2017年1月24日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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