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Completed

NCT Number: NCT01823380

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

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test

Procedure

Blood test

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 4, 2013
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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