T Cell Phenotypes in Amyotropic Lateral Sclerosis (ALS), Influence of Vitamin D
Condition: ALS
Study type: Interventional

Summary: 
      ALS is a devastative disorder characterized by motor neuron degeneration. Median survival is
      3 years after onset, but may vary from a few months to more than 30 years. Various factors
      have been suspected to play a role in such a variation, but recently, it has been described
      that regulatory T-lymphocytes (T regs) may mediate ALS progression and survival. Vitamin D is
      an hormone know to regulated T reg function in vivo and in vitro. It have recently
      demonstrated that vitamin D (VD) levels correlated with ALS prognosis. The investigator want
      to go further in the study of the immune processes that could modulate prognosis in ALS. This
      could allow proposing VD as a potential treatment of ALS in a future trial. More largely,
      this could reinforce arguments in favor of an immune intervention to attenuate the severity
      of this devastating disorder.
    

Detailed description: 
      ALS is a devastative disorder characterized by motor neuron degeneration. Median survival is
      3 years after onset, but may vary from a few months to more than 30 years. Various factors
      have been suspected to play a role in such a variation, but recently, it has been described
      that regulatory T-lymphocytes (T regs) may mediate ALS progression and survival. Vitamin D is
      an hormone know to regulated T reg function in vivo and in vitro. It have recently
      demonstrated that vitamin D (VD) levels correlated with ALS prognosis and patients with a
      severe VD deficiency had a 6 time more rapid evolution than those with normal VD levels. The
      investigator want to go further in the study of the immune processes that could modulate
      prognosis in ALS. We propose 1- to study T cell phenotypes (Treg, CD4 (cluster of
      differentiation 4) -Th1, -Th17, -Th2, CD8 (cluster of differentiation 8)and NK) in ALS vs
      controls ; 2- In VD-deficient patients, to analyze the influence of a vitamin D
      supplementation on T cell phenotypes ; 3- to study the relationships between T cell
      phenotypes and ALS prognostic factors. The project will include 70 ALS patients and 27
      controls in this prospective study. VD-deficient patients will be supplemented, according to
      national recommendations for 6 months, and the evolution of T cell phenotypes will be
      followed over 1 year. We hope to demonstrate first that T cell phenotypes in ALS are
      consistent with a pro inflammatory profile, compared to controls, secondly that VD treatment
      modulates T cell phenotypes towards a non-inflammatory one and, thirdly, that inflammatory T
      cell phenotypes correlate with a worse prognosis of the disease. This could allow proposing
      VD as a potential treatment of ALS in a future trial. More largely, this could reinforce
      arguments in favor of an immune intervention to attenuate the severity of this devastating
      disorder.
    

Intervention name(s): phenotyping Tcells; Supplementation in vitamin D
Intervention type(s): Other; Other
Intervention description(s): Collecting blood for analyses of the T cells phenotypes; Supplementation in vitamin D for the patients who are deficient on vitamin D
Intervention MeSH terms: Vitamin D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic