Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Procedure: Blood sampling; Other: Gustatory sensitivity test using Taste strips; Other: Questionnaires

• Registration Number: NCT02008669
• Lead Sponsor: Lille Catholic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Primary Completion: 2017-06-09
• Study Completion: 2017-06-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Sclerosis cases	Blood sampling	All patients will undergo the following interventions * Gustatory sensitivity test using Taste strips * Blood sampling * Questionnaires
Multiple Sclerosis cases	Gustatory sensitivity test using Taste strips	All patients will undergo the following interventions * Gustatory sensitivity test using Taste strips * Blood sampling * Questionnaires
Multiple Sclerosis cases	Questionnaires	All patients will undergo the following interventions * Gustatory sensitivity test using Taste strips * Blood sampling * Questionnaires

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Presence or absence of clinical manifestations	Baseline
Score of the taste sensibility test	Baseline
Presence or absence of sociodemographic variables	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 visual analog scale for the evaluation of sleep quality	Baseline
Score of the Beck depression inventory test	Baseline	This test is a 21-question multiple-choice self-report inventory for measuring the severity of depression
Score of the Nutrition and Eating Habits Questionnaire	Baseline

Trial Locations

Locations (12)

Centre Hospitalier Universitaire de Caen; 🇫🇷 Caen, Basse-Normandie, France

Centre Hospitalier d'Arras; 🇫🇷 Arras, Nord Pas-de-Calais, France

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, Nord Pas-de-Calais, France

Centre Hospitalier Dron de Tourcoing; 🇫🇷 Tourcoing, Nord Pas-de-Calais, France

Centre Hospitalier Universitaire d'Amiens; 🇫🇷 Amiens, Picardie, France

Centre Hospitalier de Boulogne, Hôpital Duchenne; 🇫🇷 Boulogne sur Mer, Nord Pas-de-Calais, France

Centre Hospitalier de Calais; 🇫🇷 Calais, Nord Pas-de-Calais, France

Groupement des Hôpitaux de l'Institut Catholique de Lille; 🇫🇷 Lille, Nord Pas-de-Calais, France

Centre Hospitalier de Sambre-Avenois; 🇫🇷 Maubeuge, Nord Pas-de-Calais, France

Centre Hélène Borel; 🇫🇷 Raimbeaucourt, Nord Pas-de-Calais, France

Centre Hospitalier de Valenciennes; 🇫🇷 Valenciennes, Nord Pas-de-Calais, France

Centre Hospitalier de Douai; 🇫🇷 Douai, Nord-Pas De Calais, France