Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT04935034
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single-blinded crossover study'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The is a 4 arm single-blinded crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 25-hydroxyvitamin D (25(OH)D)', 'timeFrame': '8 hours', 'description': 'Change in 25(OH)D up to 8 hours after consuming the vitamin D enriched dairy drink'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'The proposed study will examine vitamin D bioavailability when 20µg of vitamin D is consumed in 5 different forms:\n\ni) a vitamin D enriched pre-formed mixed micelle dairy drink ii) a vitamin D enriched olive oil dairy drink iii) a vitamin D enriched fish oil dairy drink iv) a vitamin D enriched fat-free dairy drink', 'detailedDescription': "This postprandial study will recruit healthy males and females aged 18 and over. Upon completion of informed consent procedures and successful screening, the volunteers will complete 4 study visits. Participants will consume a standardised meal the evening before each test day, and will arrive in the morning to the research facility in UCD after an overnight fast of 12 hours.\n\nOn the study test days, volunteers will be given one of the following vitamin D treatments in a dairy drink, followed by a low-fat breakfast.\n\n1. mixed micelles\n2. olive oil\n3. fish oil\n4. fat-free\n\nParticipants will also be given a low-fat lunch 5 hours after the supplement is consumed. Volunteers will be cannulated by a trained phlebotomist on arrival, and a fasting blood sample will be taken. Following ingestion of the vitamin D supplements blood samples will be taken at 0,2,4,6, and 8 hours post ingestion. A 10mL sample will be collected at each time point. In total, 60mL of blood will be collected over 24 hours. The participant's food intake will be recorded during the visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHealthy men and women\n\nExclusion Criteria:\n\nPregnant or lactating Smokers Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc.\n\nAn inability to read, write or understand English Following a strict prescribed diet for any reason, insulin dependent diabetes, coeliac disease, Crohn's disease Disease or condition that requires chronic therapeutic nutritional or medical treatment.\n\nThose taking supplemental vitamin D Those who have been on a sun holiday in the last 2 months"}, 'identificationModule': {'nctId': 'NCT04935034', 'briefTitle': 'Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.', 'organization': {'class': 'OTHER', 'fullName': 'University College Dublin'}, 'officialTitle': 'Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.', 'orgStudyIdInfo': {'id': 'LS-20-53-OSullivan-McCourt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D enriched mixed micelles dairy drink', 'description': '20ug vitamin D in pre-formed mixed micelle dairy drink', 'interventionNames': ['Dietary Supplement: Vitamin D supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D enriched olive oil dairy drink', 'description': '20ug vitamin D in olive oil dairy drink', 'interventionNames': ['Dietary Supplement: Vitamin D supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D enriched fish oil dairy drink', 'description': '20ug vitamin D in fish oil dairy drink', 'interventionNames': ['Dietary Supplement: Vitamin D supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D enriched fat-free dairy drink', 'description': '20ug vitamin D in fat-free dairy drink', 'interventionNames': ['Dietary Supplement: Vitamin D supplement']}], 'interventions': [{'name': 'Vitamin D supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.', 'armGroupLabels': ['Vitamin D enriched fat-free dairy drink', 'Vitamin D enriched fish oil dairy drink', 'Vitamin D enriched mixed micelles dairy drink', 'Vitamin D enriched olive oil dairy drink']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'country': 'Ireland', 'facility': 'University College Dublin', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At the start of the study each participant will have a study code assigned to them. All of the data from the trials will be stored using these unique study codes. A file will be set up which will be stored in a location separate to the study data. This file will contain a list which will link each participants contact details to the corresponding ID code. All stored information will be encrypted and protected by a password that only the researcher and PI will know.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Dublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': "Aifric O'Sullivan", 'investigatorAffiliation': 'University College Dublin'}}}}