Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-28 @ 10:50 PM
Study NCT ID:
NCT00960232
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2009-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D, Blood Pressure, Lipids, Infection and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'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'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-03', 'studyFirstSubmitDate': '2009-08-14', 'studyFirstSubmitQcDate': '2009-08-14', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression score', 'timeFrame': '6 months'}, {'measure': 'Blood pressure', 'timeFrame': '6 months'}, {'measure': 'Lipid profile', 'timeFrame': '6 months'}, {'measure': 'Frequency of infections', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D', 'blood pressure', 'lipids', 'infection', 'depression'], 'conditions': ['Hypovitaminosis D']}, 'referencesModule': {'references': [{'pmid': '22790678', 'type': 'DERIVED', 'citation': 'Kjaergaard M, Waterloo K, Wang CE, Almas B, Figenschau Y, Hutchinson MS, Svartberg J, Jorde R. Effect of vitamin D supplement on depression scores in people with low levels of serum 25-hydroxyvitamin D: nested case-control study and randomised clinical trial. Br J Psychiatry. 2012 Nov;201(5):360-8. doi: 10.1192/bjp.bp.111.104349. Epub 2012 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'There are numerous indications for a relation between low serum levels of 25(OH)D and blood pressure, lipid levels, frequency of infections and tendency towards depression. Whether it is a causal relationship it is not known, and can best be studied with a vitamin D intervention. The investigators hypothesis is that supplementation with a high dose vitamin D (40.000 IU per week) will have a beneficial effect on these parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women 30 - 75 years of age\n* low serum 25(OH)D levels\n\nExclusion Criteria:\n\n* diabetes\n* other serious diseases\n* hypercalcemia'}, 'identificationModule': {'nctId': 'NCT00960232', 'briefTitle': 'Vitamin D, Blood Pressure, Lipids, Infection and Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Tromso'}, 'officialTitle': 'Vitamin D, Blood Pressure, Lipids, Infection and Depression', 'orgStudyIdInfo': {'id': 'UIT-ENDO-2009-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D', 'description': 'vitamin D 40.000 IU per weel', 'interventionNames': ['Drug: Cholecalciferol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'otherNames': ['Decristol'], 'description': '40.000 IU cholecalciferol per week for 6 months', 'armGroupLabels': ['Vitamin D']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9037', 'city': 'Tromsø', 'state': 'Tromsø', 'country': 'Norway', 'facility': 'University of Tromsø', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Rolf Jorde, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tromso'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tromso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}