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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823380
First Posted: April 4, 2013
Last Update Posted: December 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose
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.

Condition Intervention
Amyotrophic Lateral Sclerosis Procedure: Blood test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Vitamin D blood level [ Time Frame: Day 1 ]
    The vitamine D blood level will be assessed the day of the inclusion of the patient.


Enrollment: 127
Study Start Date: September 2012
Study Completion Date: September 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amyotrophic lateral sclerosis
Blood test
Procedure: Blood test
Blood test

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823380


Locations
France
UH Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: William Camu, PU PH UH Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01823380     History of Changes
Other Study ID Numbers: 8987
First Submitted: March 22, 2013
First Posted: April 4, 2013
Last Update Posted: December 7, 2015
Last Verified: September 2015

Keywords provided by University Hospital, Montpellier:
Amyotrophic lateral sclerosis
Vitamin D
Blood Levels

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents