Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-03 @ 12:34 AM
Study NCT ID:
NCT02243800
Status:
UNKNOWN
Last Update Posted:
2016-07-29
First Post:
2014-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in functional disability measured by the HAQ between the treated group and the placebo group.', 'timeFrame': 'at day 1'}], 'secondaryOutcomes': [{'measure': 'The EULAR response criteria', 'timeFrame': 'at day 1'}, {'measure': 'ACR response criteria', 'timeFrame': 'at day 1'}, {'measure': 'The number of tender joints', 'timeFrame': 'at day 1'}, {'measure': 'The number of swollen joints', 'timeFrame': 'at day 1'}, {'measure': 'VAS pain', 'timeFrame': 'at day 1'}, {'measure': 'EVA activity', 'timeFrame': 'at day 1'}, {'measure': 'Parameters of inflammation', 'timeFrame': 'at day 1'}, {'measure': 'Asthenia collected by VAS and FACIT - tiredness', 'timeFrame': 'at day 1'}, {'measure': 'The impact of RA activity (RAID)', 'timeFrame': 'at day 1'}, {'measure': 'Quality of life (SF-36, EMIR, MOS, PASS)', 'timeFrame': 'at day 1'}]}, 'conditionsModule': {'keywords': ['Vitamin D', 'Rheumatoid arthritis', 'Cholecalciferol'], 'conditions': ['Rheumatoid Arthritis', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and decreases pro-inflammatory process. There is an inverse relationship, at least in some epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence and / or activity of RA. The hypothesis of our study is that natural vitamin D supplementation in patients with RA and a vitamin D deficiency (vitamin D \\<30 ng / mL) improves functional disability.', 'detailedDescription': 'This is an interventional, multicenter (13 rheumatology units) randomized, double-blinded study against placebo, lasting 24 weeks. The main objective is to demonstrate that treatment with cholecalciferol improves functional disability (HAQ) in patients with RA not in remission (DAS28 VS\\> 2.6 and the investigator does not think to change the treatment in the 3 months after enrolment) and vitamin D deficiency (vitamin D \\<30 ng / ml). Secondary objectives will be to examine whether there is a decrease in disease activity (tender joint count, swollen joint count, VAS, EVA activity, ESR, CRP, EULAR criteria, ACR), a decrease in fatigue (FACIT EVA - fatigue), improved quality of life (SF36, EMIR, PASS, MOS) and the impact of RA (RAID).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with RA (ACR 1987) not in remission (DAS28\\> 2.6) in whom no change in treatment is considered by the investigator for at least 3 months, DMARD stable RA for at least 3 months and lack of infiltration in the last 2 months\n\n\\- Serum 25-OH vitamin D \\<30 ng / ml\n\nExclusion Criteria:\n\n* Arthritis resulting in class IV functional disability (according to the ACR criteria)\n* Hypercalcemia (serum calcium\\> 2.6 mmol/L) and/or known hypercalciuria (calcium excretion\\> 4 mg / kg / day), history of renal colic, thiazideic therapy.\n* Known hypersensitivity to vitamin D\n* Patient refused to sign the consent form, pregnant or nursing women, patients minor, major patients under protection of the Act'}, 'identificationModule': {'nctId': 'NCT02243800', 'acronym': 'SCORPION', 'briefTitle': 'Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency', 'orgStudyIdInfo': {'id': 'CHU-0205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cholecalciferol', 'description': 'One group will receive the study treatment: cholecalciferol One group will receive placebo', 'interventionNames': ['Other: cholecalciferol versus placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'One group will receive the study treatment: cholecalciferol One group will receive placebo', 'interventionNames': ['Other: cholecalciferol versus placebo']}], 'interventions': [{'name': 'cholecalciferol versus placebo', 'type': 'OTHER', 'armGroupLabels': ['cholecalciferol', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Martin SOUBRIER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'CRINEX Laboratory', 'class': 'UNKNOWN'}, {'name': 'BP 337 - 3 rue de Gentilly', 'class': 'UNKNOWN'}, {'name': '92541 MONTROUGE Cedex FRANCE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}