Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-29 @ 10:00 AM
Study NCT ID:
NCT03552666
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2018-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-05-11', 'releaseDate': '2021-04-19'}], 'estimatedResultsFirstSubmitDate': '2021-04-19'}}, '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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, examiner-blind, comparator-controlled crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-08', 'studyFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Absorption', 'timeFrame': 'baseline, 3, 6, 10, 24 and 48 hours', 'description': 'A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)'}], 'secondaryOutcomes': [{'measure': 'Absorption Rate', 'timeFrame': '0 to 48 hours', 'description': 'A comparison of absorption rate across the two vitamin formulations (gummy vs. tablet)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D'], 'conditions': ['Bioequivalence of Vitamin D in Healthy Adults']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to evaluate and compare the bioequivalence between a single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet in healthy adults.', 'detailedDescription': 'The investigators hypothesize that the gummy and tablet preparations of vitamin D3 supplement will be biologically equivalent, as defined by the absence of a statistically significant difference in bioavailability measured as blood levels of vitamin D3 after administration of the same oral dose of vitamin D3 as gummy and tablet supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females not of childbearing potential (i.e., hysterectomy, oophorectomy, bilateral tubal ligation or postmenopausal) or females of childbearing potential that agree to use a medically approved method of birth control such as hormonal contraceptives, double-barrier, non-hormonal intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner\n* BMI 18.5 to 29.9 kg/m2\n* Agrees to maintain current level of physical activity throughout the study\n* Agrees to wear sunblock of at least SPF 45 during the study and not to have excessive sun exposure (no more than 1 hour without sunblock)\n\nExclusion Criteria:\n\n* Women who are pregnant to be determined by UPT (urine pregnancy test), breastfeeding, or planning to become pregnant during the course of the study\n* Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or GERD within the past 3 months\n* Significant gastrointestinal disease, history of malabsorption, or history of irritable bowel syndrome and related disorders\n* Unstable medical conditions as determined by the principal investigator\n* Clinically significant abnormal laboratory results on CBC or BMP at screening\n* Cancer chemotherapy/radiation treatment within the 3 months prior to enrollment\n* Metabolic disease\n* History of kidney stones\n* Use of prescription or over the counter products known to interact with vitamin D within 72 hours of randomization and during the trial such as aspirin and NSAIDs, aluminum, iron and proton pump inhibitors\n* Use of acute over the counter medication within 72 hours of test product dosing\n* Smokers\n* Consumption of more than 2 alcoholic drinks per day\n* Drug abuse within the past year\n* Use of medicinal marijuana\n* Immunocompromised individuals such as individuals that have undergone organ transplantation or individuals diagnosed with human immunodeficiency virus (HIV)\n* Individuals who have planned surgery during the course of the trial\n* Use of St. John's wort in the last 30 days before randomization and during the study\n* Use of vitamin D, multivitamins containing vitamin D, foods or beverages fortified with vitamin D and other natural healthy products containing vitamin D, or consumption of grapefruit/ grapefruit juice within 14 days of randomization and during the study\n* Use of anticoagulants , barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications\n* History of blood/bleeding disorders\n* Anemia of any etiology defined as hemoglobin \\< 140 g/L for males and \\< 123 g/L for females\n* Blood donation in the past 3 months, or individuals planning to donate blood during the study or within 30 days of completion of study\n* Participation in a clinical research trial within 30 days prior to randomization\n* Allergy or sensitivity to any ingredient in supplements provided during the study\n* Individuals who are cognitively impaired and/or who are unable to give informed consent"}, 'identificationModule': {'nctId': 'NCT03552666', 'briefTitle': 'Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Church & Dwight Company, Inc.'}, 'officialTitle': 'A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults', 'orgStudyIdInfo': {'id': 'ST-7639N9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitafusion Extra Strength Vitamin D3 Gummy', 'description': 'A single oral dose of gummy vitamin D3 to monitor Vitamin D blood levels', 'interventionNames': ['Dietary Supplement: vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nature Made Vitamin D3 Tablet', 'description': 'A single oral dose of tablet vitamin D3 to monitor Vitamin D blood levels', 'interventionNames': ['Dietary Supplement: vitamin D3']}], 'interventions': [{'name': 'vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Nature Made Vitamin D3 Tablet', 'Vitafusion Extra Strength Vitamin D3 Gummy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08543', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Church & Dwight Co., Inc.', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Church & Dwight Company, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical University of South Carolina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-04-19', 'type': 'RELEASE'}, {'date': '2021-05-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Church & Dwight Company, Inc.'}}}}