NCT01823380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 7, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

March 22, 2013

Last Update Submit

December 4, 2015

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosisVitamin DBlood Levels

Outcome Measures

Primary Outcomes (1)

  • Vitamin D blood level

    The vitamine D blood level will be assessed the day of the inclusion of the patient.

    Day 1

Study Arms (1)

Amyotrophic lateral sclerosis

OTHER

Blood test

Procedure: Blood test

Interventions

Blood testPROCEDURE

Blood test

Amyotrophic lateral sclerosis

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breastfeeding women
  • Subject not covered by a social security scheme.
  • Subject under guardianship
  • Adult protected by the law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • William Camu, PU PH

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 4, 2013

Study Start

September 1, 2012

Primary Completion

February 1, 2014

Study Completion

September 1, 2015

Last Updated

December 7, 2015

Record last verified: 2015-09

Locations

FR(1)