Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-03 @ 3:08 AM
Study NCT ID:
NCT00570856
Status:
TERMINATED
Last Update Posted:
2007-12-19
First Post:
2007-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Folic Acid Effect on Hcy and cIMT After Kidney Tx
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-14', 'studyFirstSubmitDate': '2007-12-10', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma level of total homocysteine (tHcy)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'carotid intima-media thickness (cIMT)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Folic Acid', 'Homocysteine', 'intima-media thickness'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having hyperhomocysteinemia(tHcy\\>12.5 µmol/L in men and 11.5 µmol/L in women )\n* No evident history of CVD 4. no evidence of cigarette smoking\n* not participating in other clinical studies on evaluation of cardiac diseases and\n* not taking any lipid lowering treatment\n* not being pregnant or breast feeding a baby(women)\n* Having HIV or viral hepatitis infections.\n\nExclusion Criteria:\n\n* unstable condition of the transplanted kidney (Cr\\> 3 mg/dl, BUN \\> 50 mg/dl)\n* Cyclosporine (CsA) intoxication\n* New onset of any severe disease ( such as MI, stroke, DM, etc.).'}, 'identificationModule': {'nctId': 'NCT00570856', 'briefTitle': 'Trial of Folic Acid Effect on Hcy and cIMT After Kidney Tx', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation', 'orgStudyIdInfo': {'id': '110'}, 'secondaryIdInfos': [{'id': '110'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Folic acid supplementation', 'interventionNames': ['Drug: Folic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Folic acid', 'type': 'DRUG', 'description': 'Folic acid 5 mg/day', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo similar to the folic acid tablets, 1/day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mohsen Nafar, MD- Nephrologist', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran'}, {'name': 'Farideh Khatami, Master of Science', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran'}, {'name': 'Babak Kardavani, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Mohsen Nafar', 'oldOrganization': 'Shaheed Beheshti Medical University'}}}}