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

NCT ID: NCT01823380

Last Updated: 2015-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Amyotrophic lateral sclerosis

Blood test

Group Type: OTHER

Blood test

Intervention Type: PROCEDURE

Blood test

Interventions

Blood test

Blood test

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Camu, PU PH

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

UH Montpellier

Montpellier, , France

Countries

France

Other Identifiers

8987

Identifier Type: -

Identifier Source: org_study_id