Clinical trial NCT02008669: Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis
Official title: Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis, Fatigue, Nutritional Status, Disability.
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Correlation between the score of fatigue EMIF-SEP and the dosage of nutrients in blood (vitamins, minerals, proteins) adjusted by the EDSS status
timeFrame: Baseline
Secondary outcomes:
measure: Presence or absence of sociodemographic variables
timeFrame: Baseline
measure: Presence or absence of clinical manifestations
timeFrame: Baseline
measure: Level of physical activity and daily energy expenditure
timeFrame: Baseline
measure: Assessment of dysphagia according to the score of the Dymus Test
timeFrame: Baseline
measure: Score of the taste sensibility test
timeFrame: Baseline
measure: Score of the Beck depression inventory test
timeFrame: Baseline
measure: Score of the visual analog scale for the evaluation of sleep quality
timeFrame: Baseline
measure: Score of the Nutrition and Eating Habits Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
state: Basse-Normandie
city: Arras
country: France
facility: Centre Hospitalier d'Arras
state: Nord Pas-de-Calais
city: Boulogne sur Mer
country: France
facility: Centre Hospitalier de Boulogne, Hôpital Duchenne
state: Nord Pas-de-Calais
city: Calais
country: France
facility: Centre Hospitalier de Calais
state: Nord Pas-de-Calais
city: Lille
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
state: Nord Pas-de-Calais
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
state: Nord Pas-de-Calais
city: Maubeuge
country: France
facility: Centre Hospitalier de Sambre-Avenois
state: Nord Pas-de-Calais
city: Raimbeaucourt
country: France
facility: Centre Hélène Borel
state: Nord Pas-de-Calais
city: Tourcoing
country: France
facility: Centre Hospitalier Dron de Tourcoing
state: Nord Pas-de-Calais
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
state: Nord Pas-de-Calais
city: Douai
country: France
facility: Centre Hospitalier de Douai
state: Nord-Pas De Calais
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Cécile Donzé, MD
role: PRINCIPAL_INVESTIGATOR
References: