ALSVITALSNCT02756104
T Cell Phenotypes in Amyotropic Lateral Sclerosis (ALS), Influence of Vitamin D
A study testing phenotyping Tcells and Supplementation in vitamin D in people with ALS, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- ALS
- What is being tested?
- phenotyping Tcells and Supplementation in vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2016to 25 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- •Subject accepting to give informed consent
Who cannot join
- 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:
Show all 12Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: T Cell Phenotypes in ALS, Influence of Vitamin D
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.
Read the 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.
- Conditions
- ALS
- Being tested
- phenotyping Tcells, Supplementation in vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenotyping TcellsOther
Collecting blood for analyses of the T cells phenotypes
Supplementation in vitamin DOther
Supplementation in vitamin D for the patients who are deficient on vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Other | Healthy People on each collecting blood for phenotyping Tcells Receives: 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 Receives: Other: phenotyping Tcells; Other: Supplementation in vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of T-cell phenotypes in ALS patients and controls
Analyses of the expression of T cells phenotypes between volunteers and patients with ALS
Measured: 6 months
Secondary outcomes (3)
Influence of vitamin D treatment on T cell phenotypes
Study the relation between vitamin D blood level and the lymphocytes phenotypes between patient with initial ALS and volunteers
Measured: 6 months
Relationships between expression of T cell phenotypes and ALS criteria
Study of the relation between the lymphocytes phenotypes expression and prognostic factors of the ALS
Measured: 6 months
Relationships between vitamin D blood level and pronostic factors of the ALS
Study of the relation between vitamin D blood level and prognostic factors of the ALS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start7 Jun 2016
- Primary completion10 Sep 2018
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- ARSLA
- Responsible party
- Sponsor
- Investigators
- William CAMU, MD/PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756104
- Sponsor's protocol ID
- 9632
- Acronym
- VITALS
- Status last verified
- May 2020
- First submitted
- 18 Apr 2016
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigator communicate the global results on demand
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell Phenotypes in ALS, Influence of Vitamin D
- ClinicalTrials.gov ID
- NCT02756104
- Acronym / sponsor ID
- VITALS / 9632
- Conditions
- ALS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- ARSLA
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteers | Other | Other: phenotyping TcellsHealthy People on each collecting blood for phenotyping Tcells |
| Patients with ALS | Other | Other: phenotyping Tcells, Other: Supplementation in vitamin DPatients 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenotyping TcellsCollecting blood for analyses of the T cells phenotypes | Other | Patients with ALS, Volunteers |
| Supplementation in vitamin DSupplementation in vitamin D for the patients who are deficient on vitamin D | Other | Patients with ALS |
Primary outcome
Study of T-cell phenotypes in ALS patients and controls
Time frame: 6 months
Analyses of the expression of T cells phenotypes between volunteers and patients with ALS
3 secondary outcomes
Influence of vitamin D treatment on T cell phenotypes
Time frame: 6 months
Relationships between expression of T cell phenotypes and ALS criteria
Time frame: 6 months
Relationships between vitamin D blood level and pronostic factors of the ALS
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: Yes. The investigator communicate the global results on demand
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William CAMU, MD/PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phenotyping Tcells and Supplementation in vitamin D in people with ALS, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of T-cell phenotypes in ALS patients and controls (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.