Clinical trial: T Cell Phenotypes in Amyotropic Lateral Sclerosis (ALS), Influence of Vitamin D (NCT02756104)

Eligibility criteria:
For the patients :

        Inclusion Criteria:

          -  Man or woman with sporadic ALS and a possible, probable or definite diagnosis
             regarding the revised Escorial criteria (Forbes et al., 2001). Patients are followed
             quarterly according to national recommendations. At the end of the follow up period (1
             year for each patient), all patients remaining in the " possible " group of diagnosis
             will be excluded.

          -  Disease onset (date of onset of muscle weakness) < 18 months at the time of inclusion.

          -  Age: 30 to 80 years-old, inclusive.

          -  Patient treated by riluzole at a steady dosage since at least 3 months.

          -  Patient accepting to give informed consent

        Exclusion criteria will be :

          -  A previous treatment with VD in the preceding 2 years, whatever the dose used.

          -  Patient with an already known autoimmune disorder

          -  Patient with severe ALS involvement suggesting that survival over the 1 year follow up
             is highly unlikely (ex : tetraplegia, use of non-invasive ventilation for more than 10
             hrs/day, ALSFRS-R (ALS Functional Rating Scale) score < à 20).

          -  Pregnant or breast-feeding woman.

          -  Patient without social security insurance

        For the Controls:

        Controls will be spouses of our ALS patients. Such a group has the advantage of similar
        life style conditions, and frequently similar geographical origin. Controls and ALS
        patients will match for age and gender. Controls will also fulfill the following inclusion
        and exclusion criteria

        Inclusion criteria

        •Subject accepting to give informed consent

        Exclusion criteria

          -  Subject with an already known neurodegenerative disorder

          -  Subject with an already known autoimmune disorder

          -  Subject who received a treatment with VD in the preceding 2 years, whatever the dose
             used.

          -  Pregnant or breastfeeding woman

          -  Subject without social security insurance
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment