T Cell Phenotypes in Amyotropic Lateral Sclerosis (ALS), Influence of Vitamin D

NCT02756104 | Completed

• 1 other identifier: 9632
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ALS

Outcome Measures

Primary Outcomes (1)

• Study of T-cell phenotypes in ALS patients and controls

  Analyses of the expression of T cells phenotypes between volunteers and patients with ALS

  6 months

Secondary Outcomes (3)

• Influence of vitamin D treatment on T cell phenotypes

  6 months

• Relationships between expression of T cell phenotypes and ALS criteria

  6 months

• Relationships between vitamin D blood level and pronostic factors of the ALS

  6 months

Study Arms (2)

Volunteers

OTHER

Healthy People on each collecting blood for phenotyping Tcells

Other: phenotyping Tcells

Patients with ALS

OTHER

Patients with ALS deficient or not in Vitamin D on each collecting blood for phenotyping Tcells. The patients who are deficient in Vitamin D will have supplementation in vitamin D

Other: phenotyping Tcells; Other: Supplementation in vitamin D

Interventions

phenotyping Tcells OTHER

Collecting blood for analyses of the T cells phenotypes

Patients with ALS; Volunteers

Supplementation in vitamin D OTHER

Supplementation in vitamin D for the patients who are deficient on vitamin D

Patients with ALS

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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:
• Subject accepting to give informed consent
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• ARSLA: collaborator

Study Sites (1)

University Hospital of Montpellier

Montpellier, France

Location

MeSH Terms

Interventions

Dietary Supplements; Vitamin D

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• William CAMU, MD/PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 29, 2016
• Study Start: June 7, 2016
• Primary Completion: September 10, 2018
• Study Completion: May 25, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)