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

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ClinicalTrials.gov Identifier: NCT01823380
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: Blood test Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
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
Study Start Date : September 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Amyotrophic lateral sclerosis
Blood test
Procedure: Blood test
Blood test




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



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
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

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

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01823380     History of Changes
Other Study ID Numbers: 8987
First Posted: April 4, 2013    Key Record Dates
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