Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-19 @ 3:51 PM
Study NCT ID:
NCT02008669
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2013-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biological analysis in serum: magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between the score of fatigue EMIF-SEP and the dosage of nutrients in blood (vitamins, minerals, proteins) adjusted by the EDSS status', 'timeFrame': 'Baseline', 'description': 'The objective is to construct and validate a regression model between the scale of fatigue and biological variables'}], 'secondaryOutcomes': [{'measure': 'Presence or absence of sociodemographic variables', 'timeFrame': 'Baseline'}, {'measure': 'Presence or absence of clinical manifestations', 'timeFrame': 'Baseline'}, {'measure': 'Level of physical activity and daily energy expenditure', 'timeFrame': 'Baseline'}, {'measure': 'Assessment of dysphagia according to the score of the Dymus Test', 'timeFrame': 'Baseline'}, {'measure': 'Score of the taste sensibility test', 'timeFrame': 'Baseline'}, {'measure': 'Score of the Beck depression inventory test', 'timeFrame': 'Baseline', 'description': 'This test is a 21-question multiple-choice self-report inventory for measuring the severity of depression'}, {'measure': 'Score of the visual analog scale for the evaluation of sleep quality', 'timeFrame': 'Baseline'}, {'measure': 'Score of the Nutrition and Eating Habits Questionnaire', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis, Fatigue, Nutritional Status, Disability.'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 65 years old\n* Expended disability status scale (EDSS) between 0 and 7\n* Diagnosis of MS according to the revised criteria of McDonald\n* Clinically stable patients in the past 3 months\n* Coverage of the social insurance\n* Informed consent to participate\n\nExclusion Criteria:\n\n* Cognitive disorders that can hinder answering questionnaires\n* Presence of uncontrolled metabolic disease(s)\n* Malabsorption\n* Patients with a gastrostomy\n* Active cancer under treatment\n* Anorexia\n* Pregnancy or breast feeding\n* Severe psychiatric disorder(s)\n* No informed consent to participate\n* No coverage by the social insurance'}, 'identificationModule': {'nctId': 'NCT02008669', 'acronym': 'NUTRISEP', 'briefTitle': 'Evaluation of Nutritional Status and Fatigue in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue', 'orgStudyIdInfo': {'id': 'RC-P0022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Sclerosis cases', 'description': 'All patients will undergo the following interventions\n\n* Gustatory sensitivity test using Taste strips\n* Blood sampling\n* Questionnaires', 'interventionNames': ['Procedure: Blood sampling', 'Other: Gustatory sensitivity test using Taste strips', 'Other: Questionnaires']}], 'interventions': [{'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.', 'armGroupLabels': ['Multiple Sclerosis cases']}, {'name': 'Gustatory sensitivity test using Taste strips', 'type': 'OTHER', 'description': '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.\n\nEach 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)', 'armGroupLabels': ['Multiple Sclerosis cases']}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Evaluation of the following parameters by validated questionnaires (name of the questionnaire in bracket):\n\n* Fatigue (EMIF-SEP)\n* Dysphagia (DYMUS)\n* Food intake (semi-structured questionnaire)\n* Depression (BDI-II)\n* Daily energy expenditure (NAP)\n* Visual analog scale to study quality of sleep', 'armGroupLabels': ['Multiple Sclerosis cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'state': 'Basse-Normandie', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '62022', 'city': 'Arras', 'state': 'Hauts-de-France', 'country': 'France', 'facility': "Centre Hospitalier d'Arras", 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '62200', 'city': 'Boulogne-sur-Mer', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Hospitalier de Boulogne, Hôpital Duchenne', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '62100', 'city': 'Calais', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Hospitalier de Calais', 'geoPoint': {'lat': 50.95194, 'lon': 1.85635}}, {'zip': '59507', 'city': 'Douai', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Hospitalier de Douai', 'geoPoint': {'lat': 50.37069, 'lon': 3.07922}}, {'zip': '59000', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': "Groupement des Hôpitaux de l'Institut Catholique de Lille", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59600', 'city': 'Maubeuge', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Hospitalier de Sambre-Avenois', 'geoPoint': {'lat': 50.27875, 'lon': 3.97267}}, {'zip': '59283', 'city': 'Raimbeaucourt', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Hélène Borel', 'geoPoint': {'lat': 50.43466, 'lon': 3.09333}}, {'zip': '59208', 'city': 'Tourcoing', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Hospitalier Dron de Tourcoing', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}, {'zip': '59322', 'city': 'Valenciennes', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Hospitalier de Valenciennes', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Cécile Donzé, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Groupement des Hôpitaux de l'Institut Catholique de Lille"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}