Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT03472833
Status:
TERMINATED
Last Update Posted:
2022-02-15
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-dose Vitamin D3 in Pancreas Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine 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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'slow recruitment, patients lost to follow-up due to Covid-19 pandemic.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '25(OH) vitamin D', 'timeFrame': 'Day 60', 'description': 'Blood level of Vitamin D3'}], 'secondaryOutcomes': [{'measure': '25(OH) vitamin D', 'timeFrame': 'Day 30', 'description': 'Blood level of Vitamin D3'}, {'measure': '1,25(OH)2D vitamin D', 'timeFrame': 'Day 30', 'description': 'Blood level of 1,25(OH)2D vitamin D'}, {'measure': '1,25(OH)2D vitamin D', 'timeFrame': 'Day 60', 'description': 'Blood level of 1,25(OH)2D vitamin D'}, {'measure': 'Urine Calcium', 'timeFrame': 'Day 30', 'description': 'Calcium level in urine'}, {'measure': 'Urine Calcium', 'timeFrame': 'Day 60', 'description': 'Calcium level in urine'}, {'measure': 'Osteocalcin', 'timeFrame': 'Day 30', 'description': 'Bone marker measured in blood'}, {'measure': 'Osteocalcin', 'timeFrame': 'Day 60', 'description': 'Bone marker measured in blood'}, {'measure': 'Beta-crosslaps', 'timeFrame': 'Day 30', 'description': 'Bone marker measured in blood'}, {'measure': 'Beta-crosslaps', 'timeFrame': 'Day 60', 'description': 'Bone marker measured in blood'}, {'measure': 'Calcium', 'timeFrame': 'Day 60', 'description': 'blood measurement'}, {'measure': 'Calcium', 'timeFrame': 'Day 30', 'description': 'blood measurement'}, {'measure': 'ionized calcium', 'timeFrame': 'Day 30', 'description': 'blood measurement'}, {'measure': 'ionized calcium', 'timeFrame': 'Day 60', 'description': 'blood measurement'}, {'measure': 'creatinine', 'timeFrame': 'Day 30', 'description': 'blood measurement'}, {'measure': 'creatinine', 'timeFrame': 'Day 60', 'description': 'blood measurement'}, {'measure': 'phosphate', 'timeFrame': 'Day 60', 'description': 'blood measurement'}, {'measure': 'phosphate', 'timeFrame': 'Day 30', 'description': 'blood measurement'}, {'measure': '60-day mortality', 'timeFrame': 'Day 60', 'description': 'Number of patients who die in the specified timeframe'}, {'measure': 'hospital stay', 'timeFrame': 'Day 60', 'description': 'Hospital stay in days'}, {'measure': 'hospital readmission', 'timeFrame': 'Day 60', 'description': 'Number of readmissions'}, {'measure': 'hepcidin', 'timeFrame': 'Day 30', 'description': 'blood level marker for iron status'}, {'measure': 'hepcidin', 'timeFrame': 'Day 60', 'description': 'blood level marker for iron status'}, {'measure': 'Quality of Life questionnaire', 'timeFrame': 'Day 30', 'description': 'evaluated by EORTC questionnaire'}, {'measure': 'Quality of Life questionnaire', 'timeFrame': 'Day 60', 'description': 'evaluated by EORTC questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['V'], 'conditions': ['Pancreas Cancer', 'Vitamin D Deficiency', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Different studies have shown that a deficiency in vitamin D (≤20ng/mL) results in higher rates in morbidity and mortality rates in cancer patients. Clinical studies investigated and demonstrated altered vitamin d tissue in pancreatic cancer. But there is no prospective study evaluating the beneficiary effects of oral supplementation of vitamin d in altered vitamin d tissue from pancreatic cancer. We want to examine the effect of a high dose vitamin D3 therapy vs. a standard base dose vitamin D3 therapy in pancreas cancer patients with a vitamin D deficiency. In case of benefit in our results we could implement vitamin D3 as a supportive standard therapy in pancreatic cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nboth sexes\n\n* vitamin D deficiency(≤20ng/ml)\n* patients\\>18 years of age\n* pancreatic cancer\n* surgical intervention/non-surgical intervention\n* signed written informed consent\n\nExclusion Criteria:\n\n* patients\\<18 years of age\n* pregnancy\n* contraindication for oral vitamin D intake\n* hypercalcemia (\\> 2.65 mmol/l total calcium and/or \\> 1.35 mmol/l ionized calcium at screening)\n* other ongoing vitamin D conducted trial\n* known kidney stones, active tuberculosis or sarcoidosis (in the last 12 months)\n* metastasized pancreatic cancer\n* normal vitamin D serum levels\n* missing written informed consent'}, 'identificationModule': {'nctId': 'NCT03472833', 'acronym': 'VITdCUT', 'briefTitle': 'High-dose Vitamin D3 in Pancreas Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'VITdCUT 1.3 - 21022018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-dose', 'description': 'Intervention with high dose oral vitamin D3 supplementation.\n\n1 drop equals 400 I.U. This group will get 180.000 I.U. on day 1, and then 4000 I.U. per day for 60 days.', 'interventionNames': ['Drug: High-dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-dose', 'description': 'Intervention with standard dose oral vitamin D3 supplementation.\n\n1 drop equals 400 I.U. This group will get 800 I.U. per day for 60 days.', 'interventionNames': ['Drug: Standard dose']}], 'interventions': [{'name': 'High-dose', 'type': 'DRUG', 'description': 'Patients will receive a high dose - 180.000 I.U. (1 drop equals 400 I.U.) of Vitamin D3 orally on day 1, and then 4000 I.U. for 60 days', 'armGroupLabels': ['High-dose']}, {'name': 'Standard dose', 'type': 'DRUG', 'description': 'Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days', 'armGroupLabels': ['Standard-dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Peter Kornprat, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz, Departement for General Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}