Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT01919905
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2012-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mozzarella Cheese Vitamin D and Bioavailability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2012-03-09', 'studyFirstSubmitQcDate': '2013-08-06', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability of vitamin D fortified Mozzarella cheese after pizza baking', 'timeFrame': '2 months', 'description': 'Blood 25(OH)D levels will be measured at baseline and at the end of the study between low dose vs. high dose vitamin D group.'}], 'secondaryOutcomes': [{'measure': 'Monitoring dose safety', 'timeFrame': '2 months', 'description': 'Monitor serum calcium, phosphate, creatinine, parathyroid hormone (PTH), as well as urine calcium, phosphate, and creatinine.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mozzarella cheese fortification', 'Bioavailability of Vitamin D'], 'conditions': ['Change in Serum 25 Hydroxyvitamin D Levels']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin D in industrially fortified mozzarella cheese baked with pizza.', 'detailedDescription': 'With a growing body of evidence, the Institute of Medicine (IOM) conducted a thorough review of all available evidence to publish a report on Dietary Reference Intakes (DRIs) for calcium and vitamin D. In the absence of adequate sun exposure, acquiring the new RDA of 600-800 IU/d for vitamin D through diet alone is difficult. There is a need to increase dietary sources of vitamin D for Canadians.\n\nIn a double blind, randomized trial, our objective was to assess the effect of high temperature pizza baking on the bioavailability of vitamin D3 fortified Mozzarella cheese. We tested the following hypotheses, set a priori: 1) vitamin D3 is bioavailable from pizza baked with fortified Mozzarella cheese and heat does not significantly break down vitamin D3; and 2) the change in serum 25(OH)D (from baseline to 10 wk) will be significantly greater in the high-dose vitamin D treated group (28000 IU/wk) compared to the low dose vitamin D-treated group (200 IU/wk).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females between ages 18-70 years\n\nExclusion Criteria:\n\n* Use of vitamin D supplements in excess of 1000 IU/day\n* A history of any medical disorder that might effect vitamin D or mineral metabolism\n* Use of medications that could interfere with vitamin D metabolism\n* Potential for sun exposure ( i.e travel to a sunny destination of use of tanning beds) within the month prior to or during the study\n* History of hypercalcemia\n* Unwillingness to return for follow up'}, 'identificationModule': {'nctId': 'NCT01919905', 'briefTitle': 'Mozzarella Cheese Vitamin D and Bioavailability', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Fortification of Mozzarella Cheese With Vitamin D3: Effect of High Temperature Cooking and Bioavailability of Vitamin D3', 'orgStudyIdInfo': {'id': 'M2326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High dose', 'description': 'High dose vitamin D group receiving Mozzarella cheese/pizza with 28000 IU vitD/serving once a week', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low dose', 'description': 'Low dose vitamin D group receiving Mozzarella cheese/pizza with 200 IU vitD/serving once a week', 'interventionNames': ['Dietary Supplement: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week', 'armGroupLabels': ['High dose', 'Low dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2T9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'George Brown College', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Reinhold Vieth, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Toronto Metropolitan University', 'class': 'OTHER'}, {'name': 'George Brown College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Biochemist', 'investigatorFullName': 'Reinhold Vieth', 'investigatorAffiliation': 'University of Toronto'}}}}