Original Query: multiple sclerosis
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Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis (NUTRISEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02008669
Recruitment Status : Active, not recruiting
First Posted : December 11, 2013
Last Update Posted : August 23, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Procedure: Blood sampling Other: Gustatory sensitivity test using Taste strips Other: Questionnaires

Study Type : Observational
Actual Enrollment : 360 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue
Study Start Date : November 2013
Primary Completion Date : June 9, 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. Presence or absence of sociodemographic variables [ Time Frame: Baseline ]
  2. Presence or absence of clinical manifestations [ Time Frame: Baseline ]
  3. Level of physical activity and daily energy expenditure [ Time Frame: Baseline ]
  4. Assessment of dysphagia according to the score of the Dymus Test [ Time Frame: Baseline ]
  5. Score of the taste sensibility test [ Time Frame: Baseline ]
  6. Score of the Beck depression inventory test [ Time Frame: Baseline ]
    This test is a 21-question multiple-choice self-report inventory for measuring the severity of depression

  7. Score of the visual analog scale for the evaluation of sleep quality [ Time Frame: Baseline ]
  8. Score of the Nutrition and Eating Habits Questionnaire [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
Biological analysis in serum: magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02008669

Centre Hospitalier Universitaire de Caen
Caen, Basse-Normandie, France, 14033
Centre Hospitalier d'Arras
Arras, Nord Pas-de-Calais, France, 62022
Centre Hospitalier de Boulogne, Hôpital Duchenne
Boulogne sur Mer, Nord Pas-de-Calais, France, 62200
Centre Hospitalier de Calais
Calais, Nord Pas-de-Calais, France, 62100
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Nord Pas-de-Calais, France, 59000
Centre Hospitalier Régional Universitaire de Lille
Lille, Nord Pas-de-Calais, France, 59037
Centre Hospitalier de Sambre-Avenois
Maubeuge, Nord Pas-de-Calais, France, 59600
Centre Hélène Borel
Raimbeaucourt, Nord Pas-de-Calais, France, 59283
Centre Hospitalier Dron de Tourcoing
Tourcoing, Nord Pas-de-Calais, France, 59208
Centre Hospitalier de Valenciennes
Valenciennes, Nord Pas-de-Calais, France, 59322
Centre Hospitalier de Douai
Douai, Nord-Pas de Calais, France, 59507
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Lille Catholic University
Principal Investigator: Cécile Donzé, MD Groupement des Hôpitaux de l'Institut Catholique de Lille

Responsible Party: Lille Catholic University Identifier: NCT02008669     History of Changes
Other Study ID Numbers: RC-P0022
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by Lille Catholic University:
Multiple Sclerosis, Fatigue, Nutritional Status, Disability.

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms