Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
Study NCT ID:
NCT01754961
Status:
UNKNOWN
Last Update Posted:
2012-12-21
First Post:
2011-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Vitamin D on Inflammation in Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive 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'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-18', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2012-12-18', 'lastUpdatePostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macrophage activation', 'timeFrame': 'one week', 'description': 'As determined by serum levels and macrophage cytokine production compared to placebo and baseline'}], 'secondaryOutcomes': [{'measure': 'Liver injury', 'timeFrame': 'one week', 'description': 'Measurement of ALT/AST'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Infection', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'Chronic liver diseases are associated with inflammation. The investigators postulate that Vitamin D may modulate inflammation. Thus the investigators will study the effect of Vitamin D replacement in patients with Hepatitis C infection and Vitamin D deficiency.', 'detailedDescription': "Vitamin D appears to be a critical signaling molecule for macrophages because is needed for activation and differentiation of monocytes/macrophages. From our Preliminary Studies( VA Merit Review Grant), we propose that Vitamin D deficiency may alter the 'pro-inflammatory' ('classically activated') M1 macrophages , characterized by i\\] high expression of NOS2, TNF-a, IL-1, IL-6, IL-8, TGF-a, CXCL10, and CCL19; and ii\\] minimal expression of arginase 1 and mannose R.\n\nThe clinical relevance of these findings is suggested by the presence of activated M1 macrophages in liver biopsies from patients with severe drug-induced liver injury (unpublished observations).\n\nProspective vitamin D supplementation studies with appropriate endpoints are needed to define the role of vitamin D on inflammation in patients with chronic liver diseases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged 18 or older\n* Total 25-OH Vit D \\< 25 ng/mL\n* Infection with HCV genotype 1 (subjects infected with multiple genotypes are not eligible).\n* Plasma HCV RNA concentration of \\>100,000 IU/mL.\n* HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending \\> 3 months prior to enrollment (including, any IFN-Alpha with or without ribavirin, or other anti-HCV antiviral medication).\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding.\n* Patients with Sarcoidosis, Histoplasmosis, Lymphoma, Primary Hyperparathyroidism or Idiophatic Hypercalcemia.\n* Liver Cirrhosis.\n* Known active gastrointestinal disease that could interfere with the absorption of the test article.\n* Laboratory determinations at screening as follows:\n* Hemoglobin \\<10 g/dL .\n* Serum creatinine that is not within normal limits. However, such subjects may be enrolled if the Cockroft-Gault glomerular filtration rate (GFR) is \\> 50 mL/minute.\n* Unstable hypertension, cardiac disease or type 2 diabetes requiring changes in treatment with medications 4 weeks prior to screening or during the screening period.\n* Use of an investigational drug within 4 weeks before the screening visit or during the screening period.\n* Use of systemic immunosuppressants (including systemic, oral, or intravenous corticosteroids) or immunomodulating agents within 4 weeks before the screening visit or during the screening period.'}, 'identificationModule': {'nctId': 'NCT01754961', 'briefTitle': 'Effects of Vitamin D on Inflammation in Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Veterans Medical Research Foundation'}, 'officialTitle': 'Effects of Vitamin D on Inflammation in Liver Disease', 'orgStudyIdInfo': {'id': 'UCSD-111219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be given on Day 1 orally', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'Administration of 500,000 IU Vitamin D orally on Day 1', 'interventionNames': ['Drug: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['Vitamin D Drug'], 'description': 'Vitamin D 500,000 IU given orally on Day 1', 'armGroupLabels': ['Vitamin D']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Emulsion placebo'], 'description': 'Placebo given orally on Day 1', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Inocencio, BS', 'role': 'CONTACT', 'email': 'kcinocencio@ucsd.edu', 'phone': '619-717-1906'}, {'name': 'Mario Chojkier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC San Diego, CTRI', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Kim Inocencio, BS', 'role': 'CONTACT', 'email': 'kcinocencio@ucsd.edu', 'phone': '619-717-1906'}], 'overallOfficials': [{'name': 'Mario Chojkier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Veterans Medical Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Mario Chojkier', 'investigatorAffiliation': 'Veterans Medical Research Foundation'}}}}