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

Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Procedure: Blood sampling; Other: Gustatory sensitivity test using Taste strips; Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• France
  • Basse-Normandie
    • Caen, Basse-Normandie, France, 14033
      • Centre Hospitalier Universitaire de Caen
  • Nord Pas-de-Calais
    • Arras, Nord Pas-de-Calais, France, 62022
      • Centre Hospitalier d'Arras
    • Boulogne sur Mer, Nord Pas-de-Calais, France, 62200
      • Centre Hospitalier de Boulogne, Hôpital Duchenne
    • Calais, Nord Pas-de-Calais, France, 62100
      • Centre hospitalier de Calais
    • Lille, Nord Pas-de-Calais, France, 59000
      • Groupement des Hôpitaux de l'Institut Catholique de Lille
    • Lille, Nord Pas-de-Calais, France, 59037
      • Centre Hospitalier Regional Universitaire de Lille
    • Maubeuge, Nord Pas-de-Calais, France, 59600
      • Centre Hospitalier de Sambre-Avenois
    • Raimbeaucourt, Nord Pas-de-Calais, France, 59283
      • Centre Hélène Borel
    • Tourcoing, Nord Pas-de-Calais, France, 59208
      • Centre Hospitalier Dron de Tourcoing
    • Valenciennes, Nord Pas-de-Calais, France, 59322
      • Centre hospitalier de valenciennes
  • Nord-Pas De Calais
    • Douai, Nord-Pas De Calais, France, 59507
      • Centre Hospitalier de Douai
  • Picardie
    • Amiens, Picardie, France, 80054
      • Centre Hospitalier Universitaire d'Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the score of fatigue EMIF-SEP and the dosage of nutrients in blood (vitamins, minerals, proteins) adjusted by the EDSS status	The objective is to construct and validate a regression model between the scale of fatigue and biological variables	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of sociodemographic variables		Baseline
Presence or absence of clinical manifestations		Baseline
Level of physical activity and daily energy expenditure		Baseline
Assessment of dysphagia according to the score of the Dymus Test		Baseline
Score of the taste sensibility test		Baseline
Score of the Beck depression inventory test	This test is a 21-question multiple-choice self-report inventory for measuring the severity of depression	Baseline
Score of the visual analog scale for the evaluation of sleep quality		Baseline
Score of the Nutrition and Eating Habits Questionnaire		Baseline

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Cécile Donzé, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 9, 2017
• Study Completion (Actual): June 9, 2017

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Multiple Sclerosis, Fatigue, Nutritional Status, Disability.
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: RC-P0022