Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-26 @ 11:53 PM
Study NCT ID:
NCT07200804
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between Serum Vitamin D and Atherosclerosis', 'timeFrame': 'Immediately post-procedure (Up to 1 hour)', 'description': 'Correlation between Serum Vitamin D and Atherosclerosis was recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Serum', 'Vitamin D', 'Atherosclerosis', 'Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The study aimed to check if there is a link between good vitamin D levels in the blood and subclinical atherosclerosis in people on hemodialysis.', 'detailedDescription': 'Hemodialysis patients with End-Stage Renal Disease (ESRD) face a significantly elevated risk of cardiovascular disease (CVD) due to a complex interplay of factors. A 30-year-old HD patient faces a cardiovascular mortality risk equivalent to that of an 80-year-old in the general population, emphasizing the accelerated aging of the cardiovascular system in ESRD.\n\nVitamin D may reduce inflammation and modulate immunity, lowering hypertension and dyslipidemia risks and possibly reversing vascular calcification. However, excessive supplementation can cause hypercalcemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The present cross-sectional study was carried out on 90 patients with ESRD undergoing hemodialysis at Ain Shams University or the National Institute of Nephrology and Urology from June 2021 to December 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with end-stage renal disease (ESRD) who had been on maintenance hemodialysis for at least 6 months.\n* Age of 18 years or older.\n* Patients receiving three weekly dialysis sessions using a bicarbonate-based dialysate with anticoagulants.\n\nExclusion Criteria:\n\n* Patients with active infections, malignancies, autoimmune diseases, or pre-existing cardiovascular conditions.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07200804', 'briefTitle': 'Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Exploring the Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients: A Cross-sectional Study', 'orgStudyIdInfo': {'id': 'FMASU MSO 2/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients with normal carotid intima-media thickness (CIMT).', 'interventionNames': ['Diagnostic Test: Measurement of Serum Vitamin D Level']}, {'label': 'Group B', 'description': 'Patients with increased carotid intima-media thickness (CIMT).', 'interventionNames': ['Other: Measurement of Carotid Intima-Media Thickness']}], 'interventions': [{'name': 'Measurement of Serum Vitamin D Level', 'type': 'DIAGNOSTIC_TEST', 'description': 'Vitamin D is made of two types, named ergocalciferol (vitamin D2) and cholecalciferol (vitamin D3). Vitamin D2 is produced by converting ergosterol, a fungi and plants sterol, when it is exposed to light from the sun. Vitamin D3 is made differently, as it is formed in animal skin such as human skin with the help of 7-dehydrocholesterol when the skin is exposed to sunlight (UVB radiation).', 'armGroupLabels': ['Group A']}, {'name': 'Measurement of Carotid Intima-Media Thickness', 'type': 'OTHER', 'description': 'Samples were collected by measuring the carotid intima-media thickness (CIMT) with a Mind ray Real time ultrasound scanner DC-6 doppler machine that has a probe at a frequency of 7.5 MHz. The measurement was done from three different sites each 1 cm proximal to the carotid bulb. The average of three values was taken to determine the final value. If CIMT \\> 0.8 mm, it was defined as thickened. The measurements adhered to the Mannheim CIMT Consensus (2004-2006)', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Internal Medicine and Nephrology, Faculty of Medicine, Ain shams University, Cairo, Egypt.', 'investigatorFullName': 'Ashraf Hassan', 'investigatorAffiliation': 'Ain Shams University'}}}}