NCT02756104: VITALS

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

Completed NA Last updated 29 May 2020

What this trial tests

NA trial testing phenotyping Tcells in ALS in 97 participants. Completed in 25 May 2020.

Timeline

7 June 2016

Primary endpoint
10 September 2018

25 May 2020

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	97
Start date	7 June 2016
Primary completion	10 September 2018
Estimated completion	25 May 2020
Sites	1 location across France

Drugs / interventions tested

• phenotyping Tcells
• Supplementation in vitamin D

Conditions studied

• ALS — all drugs for ALS →

Sponsor

University Hospital, Montpellier

Who can join

Adults 30 to 80, any sex, with ALS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. From pathogenesis to therapy: the emerging role of regulatory T cells in amyotrophic lateral sclerosis.
   Zhang N, Su WM, Chen T, Zhang Q, et al · · 2026 · PMID 41639687 · DOI 10.1186/s12974-025-03677-z