Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis (NUTRISEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Lille Catholic University
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University
ClinicalTrials.gov Identifier:
NCT02008669
First received: December 3, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of disability after injury accidents in young adults. Among the many symptoms, fatigue is very common with a significant impact on quality of life. Also, the disability caused by multiple sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often deficient in this population with consequences in physical performance such as endurance and muscle strength. We propose to study the link between fatigue and shortcomings encountered in a defined population of MS patients.


Condition Intervention
Multiple Sclerosis
Procedure: Blood sampling
Other: Gustatory sensitivity test using Taste strips
Other: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue

Resource links provided by NLM:


Further study details as provided by Lille Catholic University:

Primary Outcome Measures:
  • Correlation between the score of fatigue EMIF-SEP and the dosage of nutrients in blood (vitamins, minerals, proteins) adjusted by the EDSS status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The objective is to construct and validate a regression model between the scale of fatigue and biological variables


Secondary Outcome Measures:
  • Presence or absence of sociodemographic variables [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Presence or absence of clinical manifestations [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Level of physical activity and daily energy expenditure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Assesment of dysphagia according to the score of the Dymmus Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Score of the taste sensibility test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Score of the Beck depression inventory test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This test is a 21-question multiple-choice self-report inventory for measuring the severity of depression

  • Score of the visual analog scale for the evaluation of sleep quality [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Score of the Nutrition and Eating Habits Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biological analysis in serum: magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.


Estimated Enrollment: 360
Study Start Date: November 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Multiple Sclerosis cases

All patients will undergo the following interventions

  • Gustatory sensitivity test using Taste strips
  • Blood sampling
  • Questionnaires
Procedure: Blood sampling
A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.
Other: Gustatory sensitivity test using Taste strips

16 Taste Strips impregnated with 4 flavors (sweet, sour, salty, bitter, each flavor present at 4 different concentrations), are offered to the patient one after the other in a so-called pseudorandomized sequence. The task of the patient is to choose one of the following answers: sweet / sour / salty / bitter / no taste.

Each correct answer is granted one point. In addition to the impregnated strips, two tasteless strips can be integrated in the examination at any point of time (no point)

Other: Questionnaires

Evaluation of the following parameters by validated questionnaires (name of the questionnaire in bracket):

  • Fatigue (EMIF-SEP)
  • Dysphagia (DYMUS)
  • Food intake (semi-structured questionnaire)
  • Depression (BDI-II)
  • Daily energy expenditure (NAP)
  • Visual analog scale to study quality of sleep

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with MS defined according to the revised diagnostic criteria of Mac Donald, with ages between 18 to 65 years with an Expended disability status scale (EDSS) between 0 and 7 and followed in the services of neurology or physical medicine and rehabilitation.

Criteria

Inclusion Criteria:

  • Patients between 18 and 65 years old
  • Expended disability status scale (EDSS) between 0 and 7
  • Diagnosis of MS according to the revised criteria of McDonald
  • Clinically stable patients in the past 3 months
  • Coverage of the social insurance
  • Informed consent to participate

Exclusion Criteria:

  • Cognitive disorders that can hinder answering questionnaires
  • Presence of uncontrolled metabolic disease(s)
  • Malabsorption
  • Patients with a gastrostomy
  • Active cancer under treatment
  • Anorexia
  • Pregnancy or breast feeding
  • Severe psychiatric disorder(s)
  • No informed consent to participate
  • No coverage by the social insurance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008669

Contacts
Contact: Jean Jacques Vitagliano, PhD, CTC +33 3 20 44 71 28 Vitagliano.Jean-Jacques@ghicl.net
Contact: Gabriela Certad, MD, PhD +33 3 20 22 52 69 certad.gabriela@ghicl.net

Locations
France
Centre Hospitalier Universitaire de Caen Recruiting
Caen, Basse-Normandie, France, 14033
Principal Investigator: Gilles Defer, MD         
Sub-Investigator: Sophie Derache, MD         
Centre Hospitalier d'Arras Recruiting
Arras, Nord Pas-de-Calais, France, 62022
Principal Investigator: Patrick Le Coz, MD         
Centre Hospitalier de Boulogne, Hôpital Duchenne Recruiting
Boulogne sur Mer, Nord Pas-de-Calais, France, 62200
Principal Investigator: Philippe Devos, MD         
Centre Hospitalier de Calais Recruiting
Calais, Nord Pas-de-Calais, France, 62100
Principal Investigator: Olivier Dereeper, MD         
Centre Hospitalier Régional Universitaire de Lille Recruiting
Lille, Nord Pas-de-Calais, France, 59037
Principal Investigator: Patrick Vermersch, MD, PhD         
Groupement des Hôpitaux de l'Institut Catholique de Lille Recruiting
Lille, Nord Pas-de-Calais, France, 59000
Principal Investigator: Cécile Donzé, MD         
Sub-Investigator: Arnaud Kwiatkowski, MD         
Sub-Investigator: Charlotte Crinquette, MD         
Sub-Investigator: Hichem Khenioui, MD         
Sub-Investigator: Patrick Hautecoeur, MD, PhD         
Centre Hospitalier de Sambre-Avenois Not yet recruiting
Maubeuge, Nord Pas-de-Calais, France, 59600
Principal Investigator: Thierry Rosolacci, MD         
Sub-Investigator: Veronique Neuville, MD         
Centre Hélène Borel Recruiting
Raimbeaucourt, Nord Pas-de-Calais, France, 59283
Principal Investigator: Brigitte Dubus, MD         
Sub-Investigator: Hélène Bue, MD         
Centre Hospitalier Dron de Tourcoing Recruiting
Tourcoing, Nord Pas-de-Calais, France, 59208
Principal Investigator: Didier Ferriby, MD         
Centre Hospitalier de Valenciennes Recruiting
Valenciennes, Nord Pas-de-Calais, France, 59322
Principal Investigator: Albert Verier, MD         
Centre Hospitalier Universitaire d'Amiens Recruiting
Amiens, Picardie, France, 80054
Principal Investigator: Abdullatif Al Khedr, MD         
Sponsors and Collaborators
Lille Catholic University
Investigators
Principal Investigator: Cécile Donzé, MD Groupement des Hôpitaux de l'Institut Catholique de Lille
  More Information

No publications provided

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02008669     History of Changes
Other Study ID Numbers: RC-P0022
Study First Received: December 3, 2013
Last Updated: July 23, 2014
Health Authority: France: Ministry of Health

Keywords provided by Lille Catholic University:
Multiple Sclerosis, Fatigue, Nutritional Status, Disability.

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Fatigue
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014