Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-29 @ 9:44 AM
Study NCT ID:
NCT01997203
Status:
TERMINATED
Last Update Posted:
2013-11-28
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Vitamin D Therapy in HCV Treated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], '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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'complete patients samples required', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-27', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatitis C infection', 'vitamin D'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients.', 'detailedDescription': 'Fifty patients study group administered vit D were compared with 50 patients control group without vit D. The results showed a significant elevation in vit D levels during the time period, and significant reduction on HCV RNA from the 12th wk to reach zero level in 24th wk. Interleukin 6 (IL-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. These concentrations reduction by the effect of vit D on HCV indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration HCV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic HCV infection (positive HCV Ab more than 6 months)\n* Treated with pegylated interferon and ribavirin\n\nExclusion Criteria:\n\n* Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus\n* Previous non response to antiviral therapy.\n* Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.'}, 'identificationModule': {'nctId': 'NCT01997203', 'acronym': 'VD-HCV', 'briefTitle': 'Long Term Vitamin D Therapy in HCV Treated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': "Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment", 'orgStudyIdInfo': {'id': 'HCV-VD2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCV patients under treatment', 'description': 'Fifty patients study group administered vitamin D were compared with 50 patients control group without vitamin D.\n\nDose of vitamin D 15,000 IU/week', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'NO_INTERVENTION', 'label': 'HCV without Vit D'}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['pegylated interferon', 'ribavirin'], 'description': 'vitamin D was given to 50 patients (HCV under treatment)', 'armGroupLabels': ['HCV patients under treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bny Swif', 'state': 'Bny Swif', 'country': 'Egypt', 'facility': 'Tropical Medicine department, Bny swif university'}, {'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Medical biochemistry department, Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dina Sabry', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical biochemistry, Cairo university'}, {'name': 'Mohamed M Tawfic', 'role': 'STUDY_CHAIR', 'affiliation': 'Tropical Medicine department, bny swif university'}, {'name': 'Yehia M Korriem', 'role': 'STUDY_CHAIR', 'affiliation': 'Tropical Medicine department, bny swif university'}, {'name': 'Nadia A Abdelkader', 'role': 'STUDY_CHAIR', 'affiliation': 'Tropical Medicine department, Ain Shams university'}, {'name': 'Amany Y Elkazaz', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Biochemistry, faculty of Medicine Suez Canal University'}, {'name': 'Mohamed Ghussin', 'role': 'STUDY_CHAIR', 'affiliation': 'Biochemistry department, faculty of Pharmacology Ghazza University.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Nadia AbdelAaty AbdelKader', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ass. prof. Tropical Medicine - Ain Shams University', 'investigatorFullName': 'Dr. Nadia AbdelAaty AbdelKader', 'investigatorAffiliation': 'Ain Shams University'}}}}