Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-04-14 @ 1:22 PM
Study NCT ID:
NCT02930434
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-11', 'studyFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum 25-hydroxyvitamin D concentration', 'timeFrame': 'at end of Antarctic residency or 1 year (90-365 days), whichever came first', 'description': 'In Antarctic inhabitants not supplemented with VD that exit Antarctica before start of RCT phase of study.'}], 'secondaryOutcomes': [{'measure': 'sun exposure', 'timeFrame': 'at 0, 6, 12 months of Antarctic residency', 'description': 'questionnaires'}, {'measure': 'sleep pattern', 'timeFrame': 'at 0, 6, 12 months of Antarctic residency', 'description': 'questionnaires'}, {'measure': 'food intake of VD', 'timeFrame': 'at 0, 6, 12 months of Antarctic residency', 'description': 'Food frequency questionnaire'}, {'measure': 'serum biomarkers for bone metabolism', 'timeFrame': 'at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first', 'description': 'intact PTH, calcium phosphorus, alkaline phosphatases, VD-binding protein'}, {'measure': 'serum high-sensitivity C-reactive protein (hsCRP)', 'timeFrame': 'at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first'}, {'measure': 'serum cathelicidin (LL-37) concentration', 'timeFrame': 'at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'cholecalciferol', 'Antarctica', 'Chile', 'cathelicidin', 'bone metabolism', 'cardiovascular risk'], 'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate vitamin D (VD) deficiency in the population of Chilean Antarctica and evaluate the efficacy and safety of VD supplementation to decrease VD deficiency and favorably influence biomarkers for bone, cardiovascular, and immune health risk in the inhabitants of Chilean Antarctica.', 'detailedDescription': 'The present study consists of an initial cross-sectional evaluation of VD status and specific health biomarkers in inhabitants of Chilean Antarctica, followed by a randomized controlled trial evaluating two acceptable approaches of vitamin D supplementation (cholecalciferol 600 IU daily vs. 25000 IU weekly) in Antarctic inhabitants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* population of all ages living in the Chilean Antarctic territory during at least 3 months.\n\nExclusion Criteria:\n\n* acute or chronic renal disease\n* hyper or hypocalcemia\n* osteomalacia or Paget's disease of bone\n* use of VD supplements or fish oil supplements in the past month in doses higher than 400 IU daily\n* treatment for known VD deficiency in the last 6 months\n* UV phototherapy in the past month."}, 'identificationModule': {'nctId': 'NCT02930434', 'acronym': 'AntarD', 'briefTitle': 'Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants', 'orgStudyIdInfo': {'id': '15-148'}, 'secondaryIdInfos': [{'id': 'RT_28-15', 'type': 'OTHER', 'domain': 'Instituto Antártico Chileno'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard daily vitamin D3', 'description': 'Cholecalciferol 600 IU daily during one year or exit from Antarctica.', 'interventionNames': ['Dietary Supplement: cholecalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Higher weekly vitamin D3', 'description': 'Cholecalciferol 25000 IU once weekly during one year or exit from Antarctica.', 'interventionNames': ['Dietary Supplement: cholecalciferol']}], 'interventions': [{'name': 'cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin D3'], 'description': 'Administration of vitamin D3', 'armGroupLabels': ['Higher weekly vitamin D3', 'Standard daily vitamin D3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Arturo Borzutzky, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Medicine, Pontificia Universidad Católica de Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fuerza Aérea de Chile', 'class': 'OTHER_GOV'}, {'name': 'Instituto Antártico Chileno', 'class': 'UNKNOWN'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}