Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06266702
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2024-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Nutritional Technology for Vitamin D Absorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010743', 'term': 'Phospholipids'}], 'ancestors': [{'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Visit 1, Baseline Collection', 'description': 'As calculated from height in cm and weight in kg'}, {'measure': 'Adverse Events', 'timeFrame': 'Study Day 1 to Study Day 7 up to 20 Days', 'description': 'Participant reported adverse events during study duration'}], 'primaryOutcomes': [{'measure': 'Vitamin D Absorption', 'timeFrame': 'Time 0 to 24 Hours', 'description': 'Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil'}], 'secondaryOutcomes': [{'measure': 'Vitamin D Absorption - Peak', 'timeFrame': 'Time 0 to 48 Hours', 'description': 'Change in Peak serum for vitamin D in experimental versus control oil'}, {'measure': 'Vitamin D Absorption - AUC', 'timeFrame': 'Time 0 to 48 Hours', 'description': 'Change in AUC for vitamin D in experimental versus control oil'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition, Healthy']}, 'descriptionModule': {'briefSummary': 'This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants (18-55 years of age)\n* Body mass index (BMI) \\<30 kg/m2\n* Males and nonpregnant, nonlactating females\n* Free of gastrointestinal disorders that my impact nutrient absorption in the small intestine, endocrine, hepatic, renal, or bone diseases\n\nExclusion Criteria:\n\n* Use of vitamin D or calcium supplements within 3 weeks prior to the Screening Visit.\n* Use of a tanning booth/lamp within 3 weeks prior to the Screening Visit.\n* Travel to sunny location within 3 weeks prior to the Screening Visit.\n* Consumption of more than 3 alcoholic drinks per day starting 48 hours before the Screening Visit.\n* Has an allergy or intolerance to any ingredient in the study product.\n* Participating in another study that has not been approved as a concomitant study by Abbott Nutrition.\n* Use of the following medications that may have interactions with vitamin D absorption or metabolism:\n\n * Aluminum-containing phosphate binders\n * Anticonvulsants\n * Atorvastatin\n * Calcipotriene\n * Cholestyramine\n * Cytochrome P-450 3A4 substrates\n * Digoxin\n * Diltiazem\n * Orlistat\n * Thiazide diuretics\n * Corticosteroids\n * Stimulant laxatives\n * Verapamil'}, 'identificationModule': {'nctId': 'NCT06266702', 'briefTitle': 'Evaluation of a Nutritional Technology for Vitamin D Absorption', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Evaluation of a Lipid-based Nutritional Technology for Enhancing Vitamin D Absorption in Humans', 'orgStudyIdInfo': {'id': 'BL71'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1A - High Vitamin D, Experimental Oil', 'description': 'High dose Vitamin D mixed with Experimental Oil', 'interventionNames': ['Other: Experimental Oil with Phospholipids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1B - High Vitamin D, Control Oil', 'description': 'High Dose Vitamin D mixed with Control Oil', 'interventionNames': ['Other: Control Polyunsaturated Oil Blend']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2A - Low Vitamin D, Experimental Oil', 'description': 'Low dose Vitamin D mixed with Experimental Oil', 'interventionNames': ['Other: Experimental Oil with Phospholipids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2B - Low Vitamin D, Control Oil', 'description': 'Low Dose Vitamin D mixed with Control Oil', 'interventionNames': ['Other: Control Polyunsaturated Oil Blend']}], 'interventions': [{'name': 'Experimental Oil with Phospholipids', 'type': 'OTHER', 'description': 'Consumed on white bread', 'armGroupLabels': ['Group 1A - High Vitamin D, Experimental Oil', 'Group 2A - Low Vitamin D, Experimental Oil']}, {'name': 'Control Polyunsaturated Oil Blend', 'type': 'OTHER', 'description': 'Consumed on white bread', 'armGroupLabels': ['Group 1B - High Vitamin D, Control Oil', 'Group 2B - Low Vitamin D, Control Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44720', 'city': 'North Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Walsh University', 'geoPoint': {'lat': 40.87589, 'lon': -81.40234}}], 'overallOfficials': [{'name': 'Steve Hertzler', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}