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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823380
• Other study ID #: 8987
• Status: Completed
• Phase: N/A
• First received: March 22, 2013
• Last updated: December 4, 2015
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Procedure:
• Blood test
Blood test

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D blood level	The vitamine D blood level will be assessed the day of the inclusion of the patient.	Day 1	No