Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— NUTRISEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008669
• Other study ID #: RC-P0022
• Status: Completed
• Start date: November 2013
• Est. completion date: June 9, 2017

Study information

• Verified date: August 2018
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 9, 2017
• Est. primary completion date: June 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

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)
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens	Picardie
France	Centre Hospitalier d'Arras	Arras	Nord Pas-de-Calais
France	Centre Hospitalier de Boulogne, Hôpital Duchenne	Boulogne sur Mer	Nord Pas-de-Calais
France	Centre Hospitalier Universitaire de Caen	Caen	Basse-Normandie
France	Centre Hospitalier de Calais	Calais	Nord Pas-de-Calais
France	Centre Hospitalier de Douai	Douai	Nord-Pas De Calais
France	Centre Hospitalier Régional Universitaire de Lille	Lille	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 Dron de Tourcoing	Tourcoing	Nord Pas-de-Calais
France	Centre Hospitalier de Valenciennes	Valenciennes	Nord Pas-de-Calais

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presence or absence of sociodemographic variables		Baseline
Secondary	Presence or absence of clinical manifestations		Baseline
Secondary	Level of physical activity and daily energy expenditure		Baseline
Secondary	Assessment of dysphagia according to the score of the Dymus Test		Baseline
Secondary	Score of the taste sensibility test		Baseline
Secondary	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
Secondary	Score of the visual analog scale for the evaluation of sleep quality		Baseline
Secondary	Score of the Nutrition and Eating Habits Questionnaire		Baseline