Impact of Vitamin D Levels on Amyotrophic Lateral Sclerosis Progression
This study aims to investigate the relationship between Vitamin D blood levels and the progression of Amyotrophic Lateral Sclerosis (ALS), assessing your Vitamin D levels at the time of your participation.
Blood test
Central Nervous System Diseases+8
+ Metabolic Diseases
+ Nervous System Diseases
Basic Science Study
Summary
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.127 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 95 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 \<20. * Pregnant or breastfeeding women * Subject not covered by a social security scheme. * Subject under guardianship * Adult protected by the law
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location