Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT01596803
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2012-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020391', 'term': 'Muscular Dystrophy, Facioscapulohumeral'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000975', 'term': 'Antioxidants'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2012-04-05', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of muscle effort tolerance after antioxidant supplementation', 'timeFrame': 'duration study 3 years', 'description': '17-weeks evaluation of an antioxidant supplementation in order to modulate or delay oxidative insult that could be useful to maintain FSHD muscle function. At T0, each patient will perform functionnal evaluation (Exercise Tolerance (2 minutes walking test), and/or Maximal Volontary Contraction and/or Endurance of quadriceps muscles).'}], 'secondaryOutcomes': [{'measure': 'Changes in inflammatory and oxidative stress parameters after antioxidant supplementation', 'timeFrame': 'duration study 3 years', 'description': 'T0 evaluations spirometry, electrocardiogram, holter,Magnetic Resonance imaging of the both thighs,estimation muscle oxygen consumption during acute exercise . T7 venous blood samples (oxidative stress inflammatory markers)needle biopsy of the vastus lateralis muscle (oxidative stress inflammatory markers). analysis oxidative stress on muscle biochemical analyses.T7 patient receives placebo or antioxidant supplementation corresponding randomly-assigned trial. After 17 weeks supplementation the subjects will obtain venous blood samples and needle biopsy.'}, {'measure': 'Changes in muscular function after antioxidant supplementation', 'timeFrame': 'duration study 3 years', 'description': "T0 evaluations spirometry, electrocardiogram, holter Magnetic Resonance imaging of the both thighs,estimation muscle oxygen consumption . T7 venous blood samples (oxidative stress inflammatory markers)needle biopsy of the vastus lateralis muscle (oxidative stress inflammatory markers). This one-week lap's time is needed to avoid potential confounding effects of exercise-induced oxidative stress on muscle biochemical analyses.T7 patient receives placebo or antioxidant supplementation corresponding randomly-assigned trial. After 17 weeks supplementation venous blood samples and needle biopsy."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['FSHD', 'Antioxidants', 'Oxidative stress', 'Muscle function', 'Quality of life', 'Activity', '(FSHD;4q35)'], 'conditions': ['Facioscapulohumeral Muscular Dystrophy']}, 'referencesModule': {'references': [{'pmid': '25246239', 'type': 'DERIVED', 'citation': 'Passerieux E, Hayot M, Jaussent A, Carnac G, Gouzi F, Pillard F, Picot MC, Bocker K, Hugon G, Pincemail J, Defraigne JO, Verrips T, Mercier J, Laoudj-Chenivesse D. Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial. Free Radic Biol Med. 2015 Apr;81:158-69. doi: 10.1016/j.freeradbiomed.2014.09.014. Epub 2014 Sep 20.'}]}, 'descriptionModule': {'briefSummary': "On the basis of published data and the investigators' results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, the investigators propose a study to test whether or not an antioxidant supplementation has a therapeutic interest for patients with FSHD. Their results have important implications for the successful implementation of rational antioxidant therapy in FSHD in which cell loss could be linked to oxidative stress.", 'detailedDescription': 'This study will compare the effect of the therapeutic interest of an antioxidant supplementation on the functional deficits and the molecular muscle abnormalities into two groups of patients affected by FSHD, one treated with the antioxidant supplementation during 17 weeks. The antioxidant by capsule consisted of:Vitamin E (400 mg /day), Selenium (200 µg/day in the form of selenomethionine), Vitamin C (500 mg/day), Zinc (25 mg/day in the form of gluconate). The second one treated with a placebo during 17 weeks. Patients will be assigned to intervention groups by chance, and neither physician, nor patient, will know which product is administrated (study in "double blind").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FSHD patients will be recruited on the basis of:\n\n * The number of repeat units (4 to 9)\n * FSHD patients with a positive family history for FSHD\n * Not confined to a wheelchair\n * No smokers\n * No associated co-morbidity (cardiac or pulmonary disease, diabetes etc.)\n * No Medications or nutritional supplementation (vitamins and/or antioxidants) at the time of the study\n * No HIV positive\n\nExclusion Criteria:\n\n* No consent form'}, 'identificationModule': {'nctId': 'NCT01596803', 'acronym': 'FSHD', 'briefTitle': 'Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)', 'orgStudyIdInfo': {'id': '8426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vitamins minerals', 'description': 'VitE 400/d, vitC 500mg/d, Se 200µg/d (selenomethionine), Zn 25 mg/d gluconate Venous blood samples( analysis oxidative stress inflammatory markers) Needle biopsy of the vastus lateralis muscle (analysis oxidative stress inflammatory markers)', 'interventionNames': ['Procedure: Taking of blood', 'Dietary Supplement: needle biopsy of the vastus lateralis muscle', 'Dietary Supplement: Vit C Vit E Zn Se']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle', 'interventionNames': ['Procedure: Taking of blood', 'Dietary Supplement: needle biopsy of the vastus lateralis muscle', 'Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se']}], 'interventions': [{'name': 'Taking of blood', 'type': 'PROCEDURE', 'description': 'Taking venous blood samples to analyse oxidant stress', 'armGroupLabels': ['Placebo', 'vitamins minerals']}, {'name': 'needle biopsy of the vastus lateralis muscle', 'type': 'DIETARY_SUPPLEMENT', 'description': 'T0 needle biopsy of the vastus lateralis muscle (analysis of oxidative stress and inflammatory markers)During 17 weeks supplementation by Vit E, C , Zn Se After 17 weeks: veinous blood samples and needle biopsy', 'armGroupLabels': ['Placebo', 'vitamins minerals']}, {'name': 'Vit C Vit E Zn Se', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['FSHD', 'Antioxidant'], 'description': 'T0 venous blood samples and needle biopsy of the vastus lateralis muscle During 17 weeks vit E 400mg/d, Se 200µg/d, Vit C 500mg/day, Zn 25 mg/d After the supplementation of 17 weeks:venous blood samples and needle biopsy of the vastus lateralis muscle', 'armGroupLabels': ['vitamins minerals']}, {'name': 'Placebo Vit E Placebo Vit C Zn Se', 'type': 'DIETARY_SUPPLEMENT', 'description': 'venous blood samples and needle biopsy', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34294', 'city': 'Montpellier', 'state': 'Languedoc-Roussillon', 'country': 'France', 'facility': 'Montpellier University Hospital- Saint Eloi Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinical Research Project 2010', 'class': 'UNKNOWN'}, {'name': 'Association Amis FSH France', 'class': 'UNKNOWN'}, {'name': 'FSH Dutch Fondation The Netherland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}