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Study of Gene Polymorphisms Involved in the Metabolism and Action of Vitamin D in Amyotrophic Lateral Sclerosis (SLA_Vit_D)

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ClinicalTrials.gov Identifier: NCT02893605
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:
This is a case-control study performed on a biological collection. The polymorphisms present on a pre-defined list of genes will be studied for 400 Amyotrophic Lateral Sclerosis (sporadic type) DNA samples and 400 control DNA samples.

Condition or disease
Amyotrophic Lateral Sclerosis

Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Study of Gene Polymorphisms Involved in the Metabolism and Action of Vitamin D in Amyotrophic Lateral Sclerosis
Study Start Date : March 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017


Group/Cohort
Cases
Patients have a sporadic form of Amyotrophic Lateral Sclerosis.
Controls
Controls correspond to spouses/partners of patients.



Primary Outcome Measures :
  1. The polymorphisms occurring on a pre-defined set of genes [ Time Frame: Day 0 (transversal study) ]
    The genes studied are: CYP2R1, CYP27A1, CYP3A4, CYP2J2, CYP27B1, CYP24A1, VDBP, VDR.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A national biological (France) collection has been in existence since 1996 and serves as a source for patient and control samples. Patients have a sporadic form of Amyotrophic Lateral Sclerosis and controls are their spouses/partners.
Criteria

Inclusion Criteria:

  • The primary inclusion criterium is the same for that of the parent biological collection, i.e. the patients fulfill requirements for probable or definite Amyotrophic Lateral Sclerosis as defined by revised international criteria (Brooks et al 2000).
  • Additionally, included patients were followed-up by doctors at the University Hospital of Montpellier, thus enabling verification of Amyotrophic Lateral Sclerosis criteria over time.

Exclusion Criteria:

  • The patient has a familial form of Amyotrophic Lateral Sclerosis (autosomic dominant or recessive types) with or without a mutation of one of the 3 genes known to be responsible for familial forms (SOD1, TARDBP, FUS). See Bender (1998).

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): NCT02893605


Locations
France
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier Cedex 5, France, 34295
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Kevin Mouzat, MD, PhD Centre Hospitalier Universitaire de Nîmes

Publications:
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02893605     History of Changes
Other Study ID Numbers: AOI/2014/KM-01
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: August 2016

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
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents