Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05887505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-06
First Post:
2023-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-04', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association', 'timeFrame': 'During the study period'}, {'measure': 'Ratio of liver failure', 'timeFrame': '7 days pre- OP (day -7)'}, {'measure': 'Ratio of liver failure', 'timeFrame': '1 day pre- OP (day -1)'}, {'measure': 'Ratio of liver failure', 'timeFrame': '1 day post- OP (day 1)'}, {'measure': 'Ratio of liver failure', 'timeFrame': '1 day before discharge'}], 'secondaryOutcomes': [{'measure': '25(OH)D status', 'timeFrame': 'Baseline (day -7), day -1, day 1 and 1 day before discharge'}, {'measure': 'Prevalence of high PTH', 'timeFrame': 'Baseline (day -7), day -1, day 1 and 1 day before discharge'}, {'measure': 'Prevalence of hypercalcemia', 'timeFrame': 'Baseline (day -7), day -1, day 1 and 1 day before discharge'}, {'measure': 'Prevalence of hypomagnesemia', 'timeFrame': 'Baseline (day -7), day -1, day 1 and 1 day before discharge'}, {'measure': '30-day mortality', 'timeFrame': 'day 1 post-OP and 1 day before discharge'}, {'measure': 'Clinical outcomes', 'timeFrame': 'day 1 post-OP and 1 day before discharge', 'description': 'Including level of C-reactive protein and white blood cell (WBC) count'}, {'measure': 'Complications after surgery', 'timeFrame': 'day 1 post-OP and 1 day before discharge', 'description': 'Including in-hospital infectious complications, Dindo-Clavien classification, volume of ascites, duration of ascites, intra-abdominal abscess, postoperative haemorrhage, pleural effusion, wall abscess, and eventration.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D Supplementation', 'Hepatectomy', 'Perioperative'], 'conditions': ['Hepatocellular Carcinoma', 'Liver Function', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': "High concentrations of parathyroid hormone (PTH) are common in patients with hepatocellular carcinoma (HCC). This study is aimed to investigate effects of vitamin D status and its multiple mega-dosage supplementation on PTH and clinical outcomes in HCC patients before and after hepatectomy. It's a single-center, prospective, parallel, double-blind, placebo-controlled study for 120 eligible subjects. The subjects will receive consecutively 3-day intervention treatments from 7th day before surgery. 30-day postoperative mortality, postoperative complications, and laboratory data will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy\n* 2.Sign the informed consent\n\nExclusion Criteria:\n\n* 1\\. Using estrogen drugs, bisphosphonates, or drugs for bone disease.\n* 2\\. Consume calcium tablets within 2 weeks before operation\n* 3\\. Sarcoidosis, multiple myeloma\n* 4\\. Pregnant women or plan to become pregnant within 3 months after surgery\n* 5\\. Autoimmune hepatitis (AIH)\n* 6\\. Early liver recurrence\n* 7\\. Used to participate in other clinical trials'}, 'identificationModule': {'nctId': 'NCT05887505', 'briefTitle': 'Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taoyuan General Hospital'}, 'officialTitle': 'Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy', 'orgStudyIdInfo': {'id': 'TYGH111086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D group', 'description': 'Oral supplementation of 1,728,000 IU vitamin D3 in 3 days', 'interventionNames': ['Other: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Oral supplementation of placebo in 3 days', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vitamin D', 'type': 'OTHER', 'description': 'Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days', 'armGroupLabels': ['Vitamin D group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral supplementation of placebo in 3 consecutive days.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yuan-Hao Ku, MD', 'role': 'CONTACT', 'email': 'darkbravo@gmail.com', 'phone': '+886-3 3699721', 'phoneExt': '4208'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taoyuan General Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}