Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT04380467
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2016-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in CKD - Vascular Function, Structure and Immune Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': '3 months', 'description': 'Percentage of patients recruited from those eligible for the study.'}, {'measure': 'Retention rate', 'timeFrame': '6 months', 'description': 'Percentage of patients recruited who completed the follow up investigations'}, {'measure': 'Acceptability to patients of randomisation procedures', 'timeFrame': '6 months', 'description': 'Acceptability as assessed by quantitative and qualitative analysis of Participant Experience Survey'}, {'measure': 'Randomisation procedure', 'timeFrame': '6 months', 'description': 'Comparison of baseline indices of two patient groups'}, {'measure': 'Maintenance of single (observer) blinding', 'timeFrame': '6 months', 'description': 'Incidences of unblinding of study investigator'}, {'measure': 'Adherence to vitamin D supplementation', 'timeFrame': '6 months', 'description': 'Subjective adherence as assessed by Participant Experience Survey and biochemical correlation by comparison of follow up vitamin D levels'}], 'secondaryOutcomes': [{'measure': 'Witnessed change in FMD between treated and untreated subjects', 'timeFrame': '6 months', 'description': 'Flow Mediated Dilatation'}, {'measure': 'Witnessed change in CIMT between treated and untreated subjects', 'timeFrame': '6 months', 'description': 'Carotid Intima Media Thickness'}, {'measure': 'Witnessed change in T lymphocyte subset frequency between treated and untreated subjects', 'timeFrame': '6 months', 'description': 'CD4+CD28null T lymphocytes and Regulatory T cells as determined by flow cytometry of whole blood'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin D', 'Cholecalciferol', 'Chronic Kidney Disease', 'Cardiovascular Disease', 'Atherosclerosis', 'Flow Mediated Dilatation', 'Carotid Intima Media Thickness', 'CD4+CD28null T lymphocyte', 'Regulatory T lymphocyte'], 'conditions': ['Atherosclerosis', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'A pilot study to assess feasibility of methods of an observer-blinded randomised controlled trial of the effect of vitamin D supplementation in Chronic Kidney Disease and low vitamin D levels on markers of vascular function (Flow Mediated Dilatation of Brachial Artery), vascular structure (Carotid Intima Media Thickness) and Immune Regulation (frequencies of CD4+CD28null T lymphocytes ad Regulatory T lymphocytes).', 'detailedDescription': "The study is a single (observer) blinded feasibility pilot randomised study. Study subjects will be recruited from clinics run by St George's Hospital Renal Department and randomised to treatment arm or no treatment arm.\n\nIn treatment arm, six doses of vitamin D tablets (cholecalciferol 100,000 IU, five capsules total) will be administered on weeks 0, 4, 8, 12, 16 and 20. In the no-treatment arm the participants receive no cholecalciferol. Participants will have serum calcium levels measured at week 12.\n\nAll participants will undergo estimation of endothelial function, carotid intima-media thickness, CD4+CD28null and regulatory T cell frequency in week 0 and week 26. The observer will be blinded to whether the patient is in the treatment or no-treatment arm whilst the following tests are performed:\n\n1. Measurement of Brachial Artery Flow Mediated Dilatation\n2. Measurement of Carotid Intima Media Thickness\n3. Quantification of CD4+CD28null and regulatory T cell frequency\n\nThe pilot study will assess feasibility of the study methods."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-80 years\n2. Calcium \\< 2.58mmol/l\n3. On an ACE inhibitor/ARB\n4. Vitamin D \\<75nmol/l\n5. eGFR 15- 60ml/min/1.73m2 and stable\n6. Informed consent to participate\n\nExclusion Criteria:\n\n1. Patients already on Vitamin D or calcium supplementation\n2. Patients with known malignancies\n3. Patients with autoimmune conditions\n4. Patients with heart failure (ejection fraction \\<40%, Plasma NT pro-BNP\\>500pg/ml)\n5. Patients with active infection\n6. Rapidly deteriorating renal function\n7. Recent Acute coronary syndrome or cerebro-vascular event (within the last 6 months)\n8. Uncontrolled hypertension (BP\\>160 systolic)'}, 'identificationModule': {'nctId': 'NCT04380467', 'briefTitle': 'Vitamin D Supplementation in CKD - Vascular Function, Structure and Immune Regulation', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Impact of Vitamin D Supplementation on Vascular Function, Vascular Structure and Immune Regulation in Patients With Chronic Kidney Disease and Low Vitamin D Levels - A Pilot Randomised Trial', 'orgStudyIdInfo': {'id': '15.0236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D Group', 'description': 'Six doses of cholecalciferol 100,000units (5x aviticol 20,000units capsules) administered monthly over 20 weeks.', 'interventionNames': ['Dietary Supplement: Vitamin D (cholecalciferol)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No vitamin D given'}], 'interventions': [{'name': 'Vitamin D (cholecalciferol)', 'type': 'DIETARY_SUPPLEMENT', 'description': '(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks', 'armGroupLabels': ['Vitamin D Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'sw17 0QT', 'city': 'London', 'state': 'Tooting', 'country': 'United Kingdom', 'facility': 'Debasish Banerjee', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Debasish Banarjee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Georges University NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}