Multiple SclerosisNUTRISEPNCT02008669
Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Lille Catholic University at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood sampling, Gustatory sensitivity test using Taste strips and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 12 sitesFrance
- Study dates
- Nov 2013to 9 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cognitive disorders that can hinder answering questionnaires
- Presence of uncontrolled metabolic disease(s)
- Malabsorption
- Patients with a gastrostomy
- Active cancer under treatment
- Anorexia
Show all 10Show fewer
- Pregnancy or breast feeding
- Severe psychiatric disorder(s)
- No informed consent to participate
- No coverage by the social insurance
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, 80054
Centre Hospitalier d'Arras
Arras, Hauts-de-France, 62022
Centre Hospitalier de Boulogne, Hôpital Duchenne
Boulogne-sur-Mer, Hauts-de-France, 62200
Centre Hospitalier Universitaire de Caen
Caen, Basse-Normandie, 14033
Centre Hospitalier de Calais
Calais, Hauts-de-France, 62100
Centre Hospitalier de Douai
Douai, Hauts-de-France, 59507
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Hauts-de-France, 59000
Centre Hospitalier Régional Universitaire de Lille
Lille, Hauts-de-France, 59037
Centre Hospitalier de Sambre-Avenois
Maubeuge, Hauts-de-France, 59600
Centre Hélène Borel
Raimbeaucourt, Hauts-de-France, 59283
Centre Hospitalier Dron de Tourcoing
Tourcoing, Hauts-de-France, 59208
Centre Hospitalier de Valenciennes
Valenciennes, Hauts-de-France, 59322
About this study
Official title: Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue
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
- Being tested
- Blood sampling, Gustatory sensitivity test using Taste strips, Questionnaires
- Keywords
- Multiple Sclerosis, Fatigue, Nutritional Status, Disability.
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
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 stripsOther
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)
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis cases | All patients will undergo the following interventions
* Gustatory sensitivity test using Taste strips
* Blood sampling
* Questionnaires Receives: Procedure: Blood sampling; Other: Gustatory sensitivity test using Taste strips; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (8)
Presence or absence of sociodemographic variables
Measured: Baseline
Presence or absence of clinical manifestations
Measured: Baseline
Level of physical activity and daily energy expenditure
Measured: Baseline
Assessment of dysphagia according to the score of the Dymus Test
Measured: Baseline
Score of the taste sensibility test
Measured: Baseline
Score of the Beck depression inventory test
This test is a 21-question multiple-choice self-report inventory for measuring the severity of depression
Measured: Baseline
Score of the visual analog scale for the evaluation of sleep quality
Measured: Baseline
Score of the Nutrition and Eating Habits Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion9 Jun 2017
- Study completion9 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Donzé, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008669
- Sponsor's protocol ID
- RC-P0022
- Acronym
- NUTRISEP
- Status last verified
- Aug 2018
- First submitted
- 3 Dec 2013
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue
- ClinicalTrials.gov ID
- NCT02008669
- Acronym / sponsor ID
- NUTRISEP / RC-P0022
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Fatigue, Nutritional Status, Disability.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 9 Jun 2017 (actual)
- Study completion
- 9 Jun 2017 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis cases | – | Procedure: Blood sampling, Other: Gustatory sensitivity test using Taste strips, Other: QuestionnairesAll patients will undergo the following interventions * Gustatory sensitivity test using Taste strips * Blood sampling * Questionnaires |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Cognitive disorders that can hinder answering questionnaires
- Presence of uncontrolled metabolic disease(s)
- Malabsorption
- Patients with a gastrostomy
- Active cancer under treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingA blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron. | Procedure or surgery | Multiple Sclerosis cases |
| Gustatory sensitivity test using Taste strips16 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 | Multiple Sclerosis cases |
| QuestionnairesEvaluation 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 | Other | Multiple Sclerosis cases |
Primary outcome
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
8 secondary outcomes
Presence or absence of sociodemographic variables
Time frame: Baseline
Presence or absence of clinical manifestations
Time frame: Baseline
Level of physical activity and daily energy expenditure
Time frame: Baseline
Assessment of dysphagia according to the score of the Dymus Test
Time frame: Baseline
Score of the taste sensibility test
Time frame: Baseline
Score of the Beck depression inventory test
Time frame: Baseline
Score of the visual analog scale for the evaluation of sleep quality
Time frame: Baseline
Score of the Nutrition and Eating Habits Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Donzé, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Lille Catholic University at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.