Effect of Vitamin D Replacement on Immune Function and Cognition in MS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Is there evidence of immune activation in MS patients deficient in Vitamin D and does Vitamin D supplementation reverse the immune activation?
研究概览
简要总结
Assessing the immune activation in MS patients deficient in Vitamin D and whether Vitamin D supplementation reverse the immune activation
Evaluating whether Vitamin D deficiency result in lower cognitive performance in MS patients and the effect of Vitamin D supplementation on reversing the cognitive impairment?
详细描述
We will compare the immune responses in patients with Vitamin D deficiency (serum level <20ng/ml) to those of patients with normal Vitamin D (serum level >35 ng/ml). We will focus on proliferation and cytokine production to myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) peptides and on the percentage of Th1 (IFN gamma producing cells) and Th17 (IL-17 producing cells) during in vitro polarization assays. Our hypothesis is that patients with low Vitamin D have increase proliferation to MBP and MOG and increased production of pro-inflammatory cytokines (IFN gamma and IL-17) and that Vitamin D supplementation will decrease this pro-inflammatory profile.
We will measure cognitive performance in patients with Vitamin D deficiency (serum level <20ng/ml) compared to those of patients with normal Vitamin D (serum level >35 ng/ml) after adjusting for educational levels and disease duration. We hypothesize that low Vitamin D has a negative effect on cognitive performance and that Vitamin D supplementation will improve cognitive function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of Multiple Sclerosis following the revised McDonald MS diagnostic criteria
- •Male and Female Aged 18 and above
- •On interferon-β treatment (Rebif®, Avonex®, or Betaseron®)
- •No signs of active inflammation or attack or new lesions on MRI
排除标准
- •Treatment with immune modulating/ suppressive drugs other than IFN-b within 6 weeks prior to enrolment
- •Hypercalcemia
- •eglomerular filtration rate<60
- •History of primary hyperparathyroidism, hypercalcemia, renal dysfunction, cardiac disease, malignancy, or granulomatous disease
- •The occurrence of an exacerbation (defined as an episode of neurologic dysfunction lasting at least 24 hours) within 4 weeks of enrollment
- •History of dementia or related disorders
- •History of traumatic brain injury
- •Diagnosis of epilepsy or history of seizure
- •Diagnosis of psychiatric disease, substance abuse/dependence, alcohol abuse/dependence
- •Currently, on any of the following medications Lithium, or Thiazide diuretics
结局指标
主要结局
Is there evidence of immune activation in MS patients deficient in Vitamin D and does Vitamin D supplementation reverse the immune activation?
时间窗: 3months
We will compare the immune responses in patients with Vitamin D deficiency (serum level \<20ng/ml) to those of patients with normal Vitamin D (serum level \>35 µg/ml). We will focus on proliferation and cytokine production to myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) peptides and on the percentage of Th1 (IFN gamma producing cells) and Th17 (IL-17 producing cells) during in vitro polarization assays. Our hypothesis is that patients with low Vitamin D have increase proliferation to MBP and MOG and increased production of pro-inflammatory cytokines (IFN gamma and IL-17) and that Vitamin D supplementation will decrease this pro-inflammatory profile.
次要结局
- Does Vitamin D deficiency result in lower cognitive performance in MS patients and does Vitamin D supplementation reverse the cognitive impairment?(3 months)
研究者
Samia Khoury
Professor
American University of Beirut Medical Center