Clinical trial NCT01823380: Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype
Official title: Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
Vitamin D
Blood Levels
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Vitamin D blood level
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: UH Montpellier
name: William Camu, PU PH
role: PRINCIPAL_INVESTIGATOR
References: