Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT05336994
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2022-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin/Mineral Absorption From Two Different Supplements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C067316', 'term': 'Geritol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will be randomly assigned to receive either supplement A or supplement B during the first visit. Five to seven days later, participants will receive the other supplement.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2022-03-24', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of serum Vitamin A'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of serum folate'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of serum Vitamin D'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of serum Vitamin B-12'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of plasma Vitamin C'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of serum zinc'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of serum iron'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of serum manganese'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Total area-under-the-curve of serum magnesium'}], 'secondaryOutcomes': [{'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum serum level of Vitamin A (mg/dL)'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum serum level of folate (mg/dL)'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum serum level of Vitamin D (mg/dL)'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum serum level of Vitamin B-12 (mg/dL)'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum plasma level of Vitamin C (mg/dL)'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum serum level of zinc (mg/dL)'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum serum level of iron (mg/dL)'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum serum level of manganese (mg/dL)'}, {'measure': 'Assess the serum or plasma levels of five vitamins and four minerals', 'timeFrame': '6 hours', 'description': 'Maximum serum level of magnesium (mg/dL)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minerals', 'Vitamins', 'Absorption'], 'conditions': ['Healthy Nutrition']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to evaluate the postprandial serum and plasma vitamin and mineral levels in healthy adult men and women between 18 and 32 years of age, following a single intake of a multivitamin and mineral supplement processed in two different ways.', 'detailedDescription': 'Serum or plasma levels of five vitamins and four minerals will be measured at baseline, and 1, 2, 4, and 6 hours after the intake of a multivitamin/mineral supplement processed by two different methods. The two methods involve using either conventional isolated vitamins and minerals blended together to provide approximately 100% of the Daily Value, or using the same amount of vitamins and minerals that have first been processing into liposomal forms before blending.\n\nParticipants are required to come for two study visits which are 5 to 7 days apart. Health screening will also be done at Study Visit 1. The order of supplement assignment will be randomized, performed in a double-blind manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females 18-32 years of age\n* BMI 18.5-32 kg/m2\n* Free from disease\n* Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician\n* Normal blood pressure (individuals whose average blood pressure is greater than 140/90 will be excluded from the study)\n* Suitable vein structure and access for successful placement of an indwelling catheter, as determined by our nurse phlebotomist\n\nExclusion Criteria:\n\n* Alcohol consumption \\> 3 drinks/week (i.e., 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)\n* Smoking\n* Vaping or using cannabis in any form\n* Using multivitamin/mineral supplements in the past two months\n* Currently taking supplements including botanical supplements, probiotics or fiber\n* Fruit consumption ≥ 2 cups/day\n* Vegetable consumption ≥ 3 cups/day\n* Coffee/tea ≥ 3 cups/day\n* Chronic/routine high-intensity exercise\n* Any chronic health conditions\n* Self-reported malabsorption\n* Currently taking prescription drugs\n* Indications of substance or alcohol abuse within the last 3 years\n* Unable to consent'}, 'identificationModule': {'nctId': 'NCT05336994', 'briefTitle': 'Vitamin/Mineral Absorption From Two Different Supplements', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Patterns of Plasma Vitamins and Minerals Following Intake of a Multivitamin/ Mineral Formula Produced by Two Different Manufacturing Processes', 'orgStudyIdInfo': {'id': '1692409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multivitamin/mineral supplement A to B', 'description': 'Participants will be randomly assigned to receive Supplement A and after 5-7 days of follow-up, they will receive Supplement B.', 'interventionNames': ['Dietary Supplement: Multivitamin/mineral supplement A', 'Dietary Supplement: Multivitamin/mineral supplement B']}, {'type': 'EXPERIMENTAL', 'label': 'Multivitamin/mineral supplement B to A', 'description': 'Participants will be randomly assigned to receive Supplement B and after 5-7 days of follow-up, they will receive Supplement A.', 'interventionNames': ['Dietary Supplement: Multivitamin/mineral supplement A', 'Dietary Supplement: Multivitamin/mineral supplement B']}], 'interventions': [{'name': 'Multivitamin/mineral supplement A', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of Supplement A', 'armGroupLabels': ['Multivitamin/mineral supplement A to B', 'Multivitamin/mineral supplement B to A']}, {'name': 'Multivitamin/mineral supplement B', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of Supplement B', 'armGroupLabels': ['Multivitamin/mineral supplement A to B', 'Multivitamin/mineral supplement B to A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Ragle Human Nutrition Research Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Robert M. Hackman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Nutritionist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}