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Completed

NCT Number: NCT02008669

Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Caen, Caen, Basse-Normandie, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

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

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

    Time frame: Baseline

    The objective is to construct and validate a regression model between the scale of fatigue and biological variables

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

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

Acronym: NUTRISEP

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2013
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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