Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Vitamin D blood level
研究概览
简要总结
The main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary objectives are to investigate the relationship between blood levels of vitamin D and total disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site of ALS.
详细描述
Amyotrophic lateral sclerosis is one of the most serious neurodegenerative disease, leading to death in 3 years by progressive paralysis of 4 limbs, speech, swallowing and breathing, and due to a progressive death of central and peripheral neurons. The cause of the disease is unknown, but an immunologically factor is more precisely suspected in ALS. Since 2008, the work of Immunology have shown that vitamin D was a major regulator of immunity. It regulates particularly the function of dendritic cells and regulates the immune response in macrophages. A vitamin D deficiency will induce activation of microglia. In neurology, vitamin D deficiency is associated with a greater impairment in neuronal function. This deficit is associated with a faster alteration of the microvasculature, alteration known to increase neuronal suffering and to enhance the neurodegenerative processes. The investigators postulate that ALS patients have a more severe prognosis if their vitamin D levels at the time of diagnosis is lower. The main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary objectives are to investigate the relationship between blood levels of vitamin D and total disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site of ALS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with possible, probable or definite Amyotrophic Lateral Sclerosis (ALS).
- •ALS operating for less than three years at dosage of vitamin D time.
- •Subject monitored in the center ALS of Montpellier for 6 months.
- •Subject agreeing to give his consent in writing or orally if the patient SLA is unable to write
排除标准
- •Subject has received a Vitamine D treatment in the six months preceding the inclusion
- •Subject with a clinical condition on the inclusion day that makes it highly probable death in the year (quadriplegic patient, subject ventilated for respiratory failure in ALS, major malnutrition) or with ALSFRS-R score <
- •Pregnant or breastfeeding women
- •Subject not covered by a social security scheme.
- •Subject under guardianship
- •Adult protected by the law
研究组 & 干预措施
Amyotrophic lateral sclerosis
Blood test
干预措施: Blood test (Procedure)
结局指标
主要结局
Vitamin D blood level
时间窗: Day 1
The vitamine D blood level will be assessed the day of the inclusion of the patient.
次要结局
未报告次要终点
