NCT02008669

Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Lille Catholic University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-11-01
• Primary completion: 2017-06-09
• Completion: 2017-06-09
• First posted: 2013-12-11
• Last updated: 2018-08-21

Locations

12 sites across 1 country: France