Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT06747559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-24
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vitamin D Supplementation on Postoperative Rehabilitation in Hip and Knee Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee joint function', 'timeFrame': 'From enrollment to the end of treatment at 1 year', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.'}, {'measure': 'Hip joint function', 'timeFrame': 'From enrollment to the end of treatment at 1 year', 'description': 'Harris Hip Score. The maximum score possible is 100. Results can be interpreted with the following: \\<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.'}, {'measure': 'Muscle strength', 'timeFrame': 'From enrollment to the end of treatment at 1 year', 'description': 'Using portable muscle strength tester to measure flexor and extensor muscle strength of knee or hip joint'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Hip or Knee', 'Joint Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if vitamin D supplementation affects postoperative rehabilitation in osteoarthritis patients who underwent joint arthroplasty. The main questions it aims to answer are:\n\nDoes oral vitamin D supplementation for a period of time after joint arthroplasty affect the postoperative recovery speed in patients who have vitamin D deficiency? Does oral vitamin D supplementation after joint arthroplasty affect the long-term recovery of joint functions in patients who have vitamin D deficiency?\n\nParticipants will:\n\nTake vitamin D oral supplement every day for 3 months. Visit the clinic in 1, 3, 6, 12 months after joint replacement surgery for checkups and tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Vitamin D deficiency (blood 25-hydroxyvitamin D value \\< 20ng/ml);\n2. Meeting the diagnostic criteria for hip or knee osteoarthritis;\n3. Planning to undergo hip or knee arthroplasty after clinical assessment;\n\nExclusion Criteria:\n\n1\\. Having other diseases that could cause damage to the bone or cartilage structure of the hip or knee, such as trauma, joint infection, congenital joint malformation, and systemic diseases such as rheumatoid arthritis and gout.'}, 'identificationModule': {'nctId': 'NCT06747559', 'briefTitle': 'Effects of Vitamin D Supplementation on Postoperative Rehabilitation in Hip and Knee Osteoarthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effects of Vitamin D Supplementation on Postoperative Rehabilitation in Hip and Knee Osteoarthritis Patients: a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024-1022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D oral supplement', 'description': 'Using vitamin D oral supplement that has been widely used in clinic', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'NO_INTERVENTION', 'label': 'No vitamin D supplementation'}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'Vitamin D oral supplementation', 'armGroupLabels': ['Vitamin D oral supplement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'SAHZU', 'role': 'CONTACT', 'email': 'keyanlunli_zheer@163.com', 'phone': '86057187783759'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiang Zhao, MD', 'role': 'CONTACT', 'email': 'flyingzhao@zju.edu.cn', 'phone': '8613750835297'}, {'name': 'Zihao Qu, MD', 'role': 'CONTACT', 'email': 'qu_z.h@zju.edu.cn', 'phone': '8615700079560'}], 'overallOfficials': [{'name': 'Xiang Zhao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD cannot be shared publicly due to the sponsor policy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yiwu Fuyuan Private Hospital', 'class': 'UNKNOWN'}, {'name': 'Hangzhou Xiaoshan Traditional Chinese Orthopedic Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}