Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-30 @ 1:30 PM
Study NCT ID:
NCT01399151
Status:
COMPLETED
Last Update Posted:
2014-04-22
First Post:
2011-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Vitamin D Supplementation and Immune Function
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-21', 'studyFirstSubmitDate': '2011-06-30', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cathelicidin levels in granulocytes', 'timeFrame': '0, 8, and 12 weeks'}, {'measure': 'Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells', 'timeFrame': '0, 8 and 12 weeks'}, {'measure': 'Change in serum cytokines and acute phase proteins', 'timeFrame': '0, 8 and 12 weeks'}, {'measure': 'Change in markers of response to tetanus vaccination', 'timeFrame': '0, 8, 9, 10 and 12 weeks', 'description': 'Markers of response to tetanus vaccine include tetanus-specific proliferation and production of cytokines by CD4 T-helper cells.'}, {'measure': 'Change in serum 25OH Vitamin D', 'timeFrame': '0, 4, 8, and 12 weeks'}, {'measure': 'Change in urinary calcium-to-creatinine ratio', 'timeFrame': '0, 2, 4, 6, 8 and 10 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in level of 5-lipoxygenase protein in granulocytes', 'timeFrame': '0, 8 and 12 weeks'}, {'measure': 'Change in production of leukotrienes in granulocytes', 'timeFrame': '0, 8, and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin D', 'Immune function'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ars.usda.gov/Main/docs.htm?docid=11240', 'label': 'USDA Western Human Nutrition Research Center'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis:\n\nVolunteers with vitamin D insufficiency (serum 25(OH)D 25-50 nmol/L) given intermediate or high dose vitamin D supplements (2,000 or 5,000 IU per day) will have increased production of anti-bacterial peptides and interleukin-1, decreased production of other pro-inflammatory cytokines, increased production of regulatory cytokines and an enhanced T- and B-cell response to a tetanus vaccine compared to vitamin D insufficient subjects given low dose vitamin D supplements (400 IU per day).', 'detailedDescription': 'Specific Aim 1:\n\nDetermine if high dose vitamin D supplements decrease the production of proinflammatory and increase the production of regulatory cytokines and chemokines by innate immune cells stimulated ex vivo.\n\nSpecific Aim 2:\n\nDetermine if high dose vitamin D supplements decrease serum markers of inflammation and increase serum and cellular levels of defensive molecules (e.g., cathelicidin).\n\nSpecific Aim 3:\n\nDetermine if high dose vitamin D supplements decrease blood levels of proinflammatory T-helper type 1 (Th1) and Th17 cells and increase levels of anti-inflammatory T-regulatory (Treg) and Th2 cells.\n\nSpecific Aim 4:\n\nDetermine if high dose vitamin D supplements increase antigen specific T cell and B cell responses after tetanus vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-49 (men) and 20-45 (women)\n* BMI 18.5-30\n* Serum 25OH Vitamin D 25-50 nmol/L\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Daily smoker\n* Anemia (Hgb\\<12 mg/dL for women and \\<13 mg/dL for men) determined at initial visit\n* Any report or diagnosis of disease or chronic condition that may affect vitamin D absorption such as cystic fibrosis, celiac disease, surgical removal of part of the stomach or intestines, and some forms of liver disease\n* Diagnosis of hyper parathyroidism and chronic granulomatous disease, which increases risk of hypercalcemia.\n* Planned to travel to a location at which either altitude or latitude would result in significant vitamin D synthesis during the study period.\n* Not previously vaccinated with TT, or vaccinated within five years\n* Use of steroids or antibiotics within the past 4 weeks\n* Current use of nutritional supplements that may alter immune function such as omega 3 fatty acid supplements\n* Current use of anti-inflammatory or anti-convulsion medications\n* Self reported history of significant adverse response to previous vaccinations'}, 'identificationModule': {'nctId': 'NCT01399151', 'acronym': 'FL-82', 'briefTitle': 'Assessment of Vitamin D Supplementation and Immune Function', 'organization': {'class': 'FED', 'fullName': 'USDA, Western Human Nutrition Research Center'}, 'officialTitle': 'Assessment of Vitamin D Supplementation and Immune Function', 'orgStudyIdInfo': {'id': 'WHNRC 213949-1'}, 'secondaryIdInfos': [{'id': 'USDA CRIS 5306-51530-018-00D', 'type': 'OTHER_GRANT', 'domain': 'USDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D - Treatment 1', 'description': '400 IU/day Vitamin D', 'interventionNames': ['Dietary Supplement: Vitamin D - Treatment 1']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D- Treatment 2', 'description': '2,000 IU/day Vitamin D', 'interventionNames': ['Dietary Supplement: Vitamin D - Treatment 2']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D- Treatment 3', 'description': '5,000 IU/day Vitamin D', 'interventionNames': ['Dietary Supplement: Vitamin D - Treatment 3']}], 'interventions': [{'name': 'Vitamin D - Treatment 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.', 'armGroupLabels': ['Vitamin D - Treatment 1']}, {'name': 'Vitamin D - Treatment 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.', 'armGroupLabels': ['Vitamin D- Treatment 2']}, {'name': 'Vitamin D - Treatment 3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.', 'armGroupLabels': ['Vitamin D- Treatment 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Western Human Nutrition Center, University of California Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Charles Stephensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WHNRC, ARS, University of California Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Western Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}