Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-22 @ 10:43 AM
Study NCT ID:
NCT02390505
Status:
UNKNOWN
Last Update Posted:
2023-02-09
First Post:
2015-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2015-02-16', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery', 'timeFrame': '6 months after surgery', 'description': 'Comparison of the occurrence of participants with CRPS type 1, between the two arms'}], 'secondaryOutcomes': [{'measure': 'Appearance of a complex regional pain syndrome 12 months after surgery', 'timeFrame': '12 months after surgery', 'description': 'Comparison of the occurrence of participants with CRPS type 1, between the two arms'}, {'measure': 'Tolerance', 'timeFrame': '6 months after surgery', 'description': 'Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration'}, {'measure': 'Observance to treatment', 'timeFrame': '6 months after surgery', 'description': 'The observance to the treatment is estimated based on an adherence form completed by the patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin C', 'CRPS', 'Upper limb surgery'], 'conditions': ['Complex Regional Pain Syndrome (CRPS) TYPE I']}, 'descriptionModule': {'briefSummary': 'Vitamin C with its antioxidant role has many indications. The objective of this study is to demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the upper limb.', 'detailedDescription': 'The preventive role of vitamin C on the development of CRPS type 1 was already demonstrated in traumatology and foot surgery.\n\nThe management of CRPS type 1 is long and expensive. A preventive care seems beneficial. Some studies already performed suggest a similar role in scheduled surgery of the upper limb, major provider of CRPS type 1.The aim of the study is to demonstrate a significant reduction of CRPS 1 when taking vitamin C during the perioperative period in upper limb surgery. It is a prospective, randomized, double-blind, with placebo use, in two parallel group, multicenter and national. Patients are followed by their surgeon, under the terms of monitoring their disease. Two visits are required: one at 6 months and at 12 months. The patients will be reviewed at least in the two consultations looking for CRPS type 1 according to the criteria of the International Association for the Study of Pain (IASP)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 yo\n* patients undergoing major surgery of the upper limb\n* patients able to give their consent to follow the protocol of treatment and monitoring.\n\nExclusion Criteria:\n\n* children,\n* patients under guardianship,\n* pregnant or lactating women,\n* patients with hemochromatosis,\n* allergy or known hypersensitivity to one of the molecules of treatment,\n* patients suffering or having already suffered from complex regional pain syndrome type 1 or type 2,\n* patients unable due to personal or professional mobility, to conduct post-operative follow up,\n* patients undergoing surgery with nerve suture with nerve graft, emergency surgery,\n* patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency,\n* patients with chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT02390505', 'acronym': 'SDRC', 'briefTitle': 'Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery', 'orgStudyIdInfo': {'id': 'PI2015_843_0001'}, 'secondaryIdInfos': [{'id': '2015-000145-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery', 'interventionNames': ['Drug: Vitamin C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DRUG', 'armGroupLabels': ['Vitamin C']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David Emmanuel, MD', 'role': 'CONTACT', 'email': 'david.emmanuel@chu-amiens.fr', 'phone': '+33322087167'}, {'name': 'Emmanuel DAVID, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '76031', 'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle AUQUIT-AUCKBUR, MD-PhD', 'role': 'CONTACT', 'email': 'Isabelle.Auquit@chu-rouen.fr'}, {'name': 'Isabelle AUQUIT-AUCKBUR, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '02321', 'city': 'Saint-Quentin', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mirdad MOUGHABGHAB, MD', 'role': 'CONTACT', 'email': 'sosmain@ch-stquentin.fr'}, {'name': 'Mirdad MOUGHABGHAB, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Saint-Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}], 'overallOfficials': [{'name': 'Emmanuel DAVID, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}