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Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic lateral sclerosis, Vitamin D, Blood Levels

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject with possible, probable or definite Amyotrophic Lateral Sclerosis (ALS).
  • ALS operating for less than three years at dosage of vitamin D time.
  • Subject monitored in the center ALS of Montpellier for 6 months.
  • Subject agreeing to give his consent in writing or orally if the patient SLA is unable to write

Exclusion Criteria:

  • Subject has received a Vitamine D treatment in the six months preceding the inclusion
  • Subject with a clinical condition on the inclusion day that makes it highly probable death in the year (quadriplegic patient, subject ventilated for respiratory failure in ALS, major malnutrition) or with ALSFRS-R score <20.
  • Pregnant or breastfeeding women
  • Subject not covered by a social security scheme.
  • Subject under guardianship
  • Adult protected by the law

Sites / Locations

  • UH Montpellier

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Amyotrophic lateral sclerosis

Arm Description

Blood test

Outcomes

Primary Outcome Measures

Vitamin D blood level
The vitamine D blood level will be assessed the day of the inclusion of the patient.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2013
Last Updated
December 4, 2015
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01823380
Brief Title
Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype
Official Title
Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary objectives are to investigate the relationship between blood levels of vitamin D and total disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site of ALS.
Detailed Description
Amyotrophic lateral sclerosis is one of the most serious neurodegenerative disease, leading to death in 3 years by progressive paralysis of 4 limbs, speech, swallowing and breathing, and due to a progressive death of central and peripheral neurons. The cause of the disease is unknown, but an immunologically factor is more precisely suspected in ALS. Since 2008, the work of Immunology have shown that vitamin D was a major regulator of immunity. It regulates particularly the function of dendritic cells and regulates the immune response in macrophages. A vitamin D deficiency will induce activation of microglia. In neurology, vitamin D deficiency is associated with a greater impairment in neuronal function. This deficit is associated with a faster alteration of the microvasculature, alteration known to increase neuronal suffering and to enhance the neurodegenerative processes. The investigators postulate that ALS patients have a more severe prognosis if their vitamin D levels at the time of diagnosis is lower. The main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary objectives are to investigate the relationship between blood levels of vitamin D and total disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site of ALS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic lateral sclerosis, Vitamin D, Blood Levels

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amyotrophic lateral sclerosis
Arm Type
Other
Arm Description
Blood test
Intervention Type
Procedure
Intervention Name(s)
Blood test
Intervention Description
Blood test
Primary Outcome Measure Information:
Title
Vitamin D blood level
Description
The vitamine D blood level will be assessed the day of the inclusion of the patient.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with possible, probable or definite Amyotrophic Lateral Sclerosis (ALS). ALS operating for less than three years at dosage of vitamin D time. Subject monitored in the center ALS of Montpellier for 6 months. Subject agreeing to give his consent in writing or orally if the patient SLA is unable to write Exclusion Criteria: Subject has received a Vitamine D treatment in the six months preceding the inclusion Subject with a clinical condition on the inclusion day that makes it highly probable death in the year (quadriplegic patient, subject ventilated for respiratory failure in ALS, major malnutrition) or with ALSFRS-R score <20. Pregnant or breastfeeding women Subject not covered by a social security scheme. Subject under guardianship Adult protected by the law
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Camu, PU PH
Organizational Affiliation
UH Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype

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