Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Vitamin D supplementation dose response
研究概览
简要总结
Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease progression. Patients with MS who had lower vitamin D levels were at increased risk for more clinical attacks and faster disease progression. It was also shown that patients with MS had lower vitamin D levels in serum than healthy controls. It is not clearly defined, which are the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and are safe for patients.
This double-blind randomized clinical trial was designed to compare impact of vitamin D supplementation in two different doses (1000 IU/day vs 4000 IU/day) in patients with relapsing remitting MS. The main goal of this trial is to compare dose response on vitamin D supplementation and to estimate more closely appropriate level of vitamin D in serum which triggers some of experimentally shown immunomodulatory actions.
详细描述
Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease progression. Patients with MS who had lower vitamin D levels were at increased risk for more clinical attacks and faster disease progression. It was also shown that patients with MS had lower vitamin D levels in serum than healthy controls. It is not clearly defined, which are the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and are safe for patients.
This double-blind randomized clinical trial was designed to compare impact of vitamin D supplementation during four months in winter time in two different doses (1000 IU/day vs 4000 IU/day) in patients with relapsing remitting MS. The main goal of this trial is to compare dose response on vitamin D supplementation and estimate more closely appropriate level of vitamin D in serum which triggers some of experimentally shown immunomodulatory actions. To define immunomodulatory response different laboratory, clinical and genetic tests will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing remitting MS
- •Treatment with immunomodulatory drug
- •Age 18-60 years and
- •EDSS (Expanded Disability Status Scale) score less than 5.
排除标准
- •Use of vitamin D supplements in the past 3 months
- •Pregnancy, planning pregnancy or nursing
- •Relapse of disease and corticosteroids use in past month
- •Active inflammation at the start of the study (flu, cystitis etc.)
- •Renal disease
- •Elevated levels of calcium or parathormone
- •Hypersensitivity to vitamin D preparations
- •Switching of immunomodulatory drug in past 3 months
- •Other autoimmune disease
- •History of hyperparathyroidism, liver disease, tuberculosis, sarcoidosis or kidney stones
研究组 & 干预措施
1000 IU of vitamin D per day
Half of randomized patients will receive 1000 IU of vitamin D per day
干预措施: Vitamin D (Drug)
4000 IU of vitamin D per day
Half of randomized patients will receive 4000 IU of vitamin D per day
干预措施: Vitamin D (Drug)
结局指标
主要结局
Vitamin D supplementation dose response
时间窗: 4 months
Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day.
次要结局
未报告次要终点
研究者
Saša Gselman, M.D.
M.D.
University Medical Centre Maribor