Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-04-18 @ 9:30 PM
Study NCT ID:
NCT02359266
Status:
COMPLETED
Last Update Posted:
2015-02-09
First Post:
2015-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Improves Depression in Liver Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-06', 'studyFirstSubmitDate': '2015-02-04', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes to depressive symptoms as assessed using the BDI-II score', 'timeFrame': '3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Changes to serum liver function tests, as assessed using standard clinical-chemical assays', 'timeFrame': '3 and 6 months'}, {'measure': 'Changes to bone density, as assessed using Dexa scans', 'timeFrame': 'at 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mood', 'Vitamin D deficiency', 'Adjuvant treatment'], 'conditions': ['Depression', 'Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of vitamin D replacement therapy in reducing depressive symptoms in patients with chronic liver disease and vitamin D deficiency. Patients with normal vitamin D levels will be monitored as controls, and they will not receive any intervention.', 'detailedDescription': 'Patients with chronic liver diseases regularly suffer from vitamin D deficiency and depression. A recent meta-analysis reported an inverse correlation between depression and vitamin D levels. Indeed, vitamin D receptor is present and genomic and nongenomic vitamin D receptor-mediated signalling has been described in brain.\n\nThis intervention study investigates whether vitamin D therapy ameliorates depressive symptoms in chronic liver disease patients.\n\nThe investigators hypothesise that depressive symptoms will improve upon vitamin D replacement therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women\n* over 18 years of age\n* chronic liver disease\n\nExclusion Criteria:\n\n* severe hepatic encephalopathy (CFF \\<35 Hz)\n* Interferon treatment\n* hypercalcaemia (\\>2.7 mmol/l) or hypercalciuria (\\>8.0 mmol/d) with or without hyperparathyroidism (\\>65.0 pg/ml)\n* history of calcium-containing kidney stones\n* allergy or hypersensitivity to any of the supplement ingredients: peanuts, soy, gelatin\n* sarcoidosis\n* stage IV or V Chronic Kidney Disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02359266', 'acronym': 'CLDVitD', 'briefTitle': 'Vitamin D Improves Depression in Liver Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Clinical Trial Investigating the Role of Vitamin D in the Treatment of Depression in Patients With Chronic Liver Disease', 'orgStudyIdInfo': {'id': 'SaarlandU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D supplement', 'description': '20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': 'These patients had normal vitamin D levels and did not receive any treatment with vitamin D.'}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['cholecalciferol'], 'description': 'Given to patients with existing vitamin D deficiency', 'armGroupLabels': ['Vitamin D supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Saarland University Medical Center', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'overallOfficials': [{'name': 'Frank Lammert, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Saarland University Medical Center'}, {'name': 'Caroline S Stokes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saarland University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr. Caroline Stokes', 'investigatorAffiliation': 'Universität des Saarlandes'}}}}