Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis

NCT02008669 | Completed

• 1 other identifier: RC-P0022
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 12

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Fatigue, Nutritional Status, Disability.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Multiple Sclerosis cases

All patients will undergo the following interventions * Gustatory sensitivity test using Taste strips * Blood sampling * Questionnaires

Procedure: Blood sampling; Other: Gustatory sensitivity test using Taste strips; Other: Questionnaires

Interventions

Blood sampling PROCEDURE

A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.

Multiple Sclerosis cases

Gustatory sensitivity test using Taste strips OTHER

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)

Multiple Sclerosis cases

Questionnaires OTHER

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

Multiple Sclerosis cases

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (12)

Centre Hospitalier Universitaire de Caen

Caen, Basse-Normandie, 14033, France

Location

Centre Hospitalier d'Arras

Arras, Hauts-de-France, 62022, France

Location

Centre Hospitalier de Boulogne, Hôpital Duchenne

Boulogne-sur-Mer, Hauts-de-France, 62200, France

Location

Centre Hospitalier de Calais

Calais, Hauts-de-France, 62100, France

Location

Centre Hospitalier de Douai

Douai, Hauts-de-France, 59507, France

Location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, Hauts-de-France, 59000, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, Hauts-de-France, 59037, France

Location

Centre Hospitalier de Sambre-Avenois

Maubeuge, Hauts-de-France, 59600, France

Location

Centre Hélène Borel

Raimbeaucourt, Hauts-de-France, 59283, France

Location

Centre Hospitalier Dron de Tourcoing

Tourcoing, Hauts-de-France, 59208, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, Hauts-de-France, 59322, France

Location

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80054, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cécile Donzé, MD

  Groupement des Hôpitaux de l'Institut Catholique de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 11, 2013
• Study Start: November 1, 2013
• Primary Completion: June 9, 2017
• Study Completion: June 9, 2017
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

FR (12)