Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-01-25 @ 12:33 AM
Study NCT ID:
NCT05641818
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3 (VITAD/3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between vitamin D status (deficiency) assessed by two different methods', 'timeFrame': '1 year', 'description': 'Vitamin D serum level will be measured for assessment of Vitamin D status. Risk for vitamin D deficiency will be assessed using questionaire-based screening tool. Two methods will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Serum Levels']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.nutris.org/projekti/vitamin-d', 'label': 'NUTRI-D project web site'}]}, 'descriptionModule': {'briefSummary': 'Validation of a screening tool for identification of subjects at risk for suboptimal vitamin D status. Developed questionnaire-based screening tool will be used on subjects with various risks for vitamin D deficiency, and compared with 25-OH-vitamin D levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult users and non-users of vitamin D drugs and food supplements living in Slovenia. Participants invited from the database at Nutrition Institute.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed consent form (ICF),\n* Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),\n* Did not change use of vitamin D conatining drugs/supplements for last 6 weeks\n* Willingness to follow all study procedures\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding,\n* Change in use of food supplements containing Vitamin D in last 6 weeks\n* Acute ilness\n* Mental incapacity that precludes adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT05641818', 'briefTitle': 'Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3 (VITAD/3)', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Nutrition, Slovenia (Nutris)'}, 'officialTitle': 'Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3: Screening Tool for Identification of Subjects at Risk for Suboptimal Vitamin D Status', 'orgStudyIdInfo': {'id': 'VITAD-01-2018 Part 3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Screening tool for vitamin D deficiency', 'type': 'OTHER', 'description': '(1) Determination of 25(OH) Vitamin D3 in human serum samples and (2) Question based screening tool with personal (age, gender,...), lifestyle (e.g. sun exposure, outdoor activity) and dietary factors that affect the status of vitamin D in the human body.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Nutrition Institute, Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Igor Pravst, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut za nutricionistiko'}, {'name': 'Katja Žmitek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VIST - Faculty of Applied Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Not decided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Nutrition, Slovenia (Nutris)', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Public Health, Slovenia', 'class': 'OTHER_GOV'}, {'name': 'VIST - Faculty of Applied Sciences', 'class': 'OTHER'}, {'name': 'Slovenian Research Agency', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}