Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT01131858
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2010-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-04', 'studyFirstSubmitDate': '2010-05-26', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infectious score', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Antimicrobial peptide expression in nasal fluid', 'timeFrame': '12 months'}, {'measure': 'Serum levels of 25-OH Vitamin D3', 'timeFrame': '12 months'}, {'measure': 'Consumption of antibiotics', 'timeFrame': '12 months'}, {'measure': 'Number of positive bacterial cultures in nasal swabs', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Immune Deficiency Disorder']}, 'referencesModule': {'references': [{'pmid': '26419363', 'type': 'DERIVED', 'citation': 'Bergman P, Norlin AC, Hansen S, Bjorkhem-Bergman L. Vitamin D supplementation improves well-being in patients with frequent respiratory tract infections: a post hoc analysis of a randomized, placebo-controlled trial. BMC Res Notes. 2015 Sep 29;8:498. doi: 10.1186/s13104-015-1504-2.'}, {'pmid': '26319134', 'type': 'DERIVED', 'citation': 'Bergman P, Norlin AC, Hansen S, Bjorkhem-Bergman L. Vitamin D supplementation to patients with frequent respiratory tract infections: a post hoc analysis of a randomized and placebo-controlled trial. BMC Res Notes. 2015 Aug 30;8:391. doi: 10.1186/s13104-015-1378-3.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients with primary immunodeficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75\n* Increased number of respiratory tract infections\n* At least 42 days of infections during 2008 or 2009\n* S-25 OH vitamin D3 \\< 250 nM\n* Not planning a pregnancy during the coming year\n* Accepting the use of contraceptives during 1 year\n\nExclusion Criteria:\n\n* Continuous antibiotic treatment\n* Hypercalcemia\n* Sarcoidosis\n* Kidney disease\n* Tuberculosis\n* Pregnancy\n* Kidney stone\n* Heart medication (glycosides)'}, 'identificationModule': {'nctId': 'NCT01131858', 'acronym': 'VITAPID', 'briefTitle': 'Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency', 'orgStudyIdInfo': {'id': '2009/1678-31/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'Vigantol (cholecalciferol) 4000 IE/day', 'interventionNames': ['Drug: Vigantol']}], 'interventions': [{'name': 'Vigantol', 'type': 'DRUG', 'description': 'Vigantol 4000IU/day', 'armGroupLabels': ['Vitamin D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18146', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Univerisity Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Jan Andersson, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Peter Bergman', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}