Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT03818594
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between vitamin D serum levels in winter and in summer season will be determined', 'timeFrame': '2 years', 'description': 'Vitamin D serum level will be measured once in winter (December - January) and once in summer season (August-September) for each individual. The study will be performed over two consecutive years.'}], 'secondaryOutcomes': [{'measure': 'Correlation of vitamin D serum levels with Fitzpatrick skin phototype', 'timeFrame': '2 years', 'description': 'Fitzpatrick skin phototype will be determined using Fitzpatrick self-evaluation questionnaire in combination with expert assessment in August-September.'}, {'measure': 'Correlation of vitamin D serum levels with skin colour measured in CIE Lab colour space', 'timeFrame': '2 years', 'description': 'Skin colour will be measured in CIE Lab colour space on inner and outer side of the upper arm. The measurement will be performed in August-September.'}, {'measure': 'Correlation of vitamin D serum levels with melanin index', 'timeFrame': '2 years', 'description': 'Melanin index will be measured on inner and outer side of the upper arm. The measurement will be performed in August-September.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Serum Levels']}, 'descriptionModule': {'briefSummary': 'Seasonal variations in vitamin D status will be determined on a cohort of Slovenian adults using longitudinal study design, and association between vitamin D status and different Caucasian phototypes, skin colour and melanin index investigated .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'General Slovenian adult population, men and women, skin phototypes I-IV.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed consent form (ICF),\n* Caucasian race\n* Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),\n* Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources\n* Willingness to follow all study procedures\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding,\n* Known or suspected allergy to any ingredient of the tested products in Part 2,\n* Pronounced avoidance of sunshine (eg reporting of allergy to the sun)\n* Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion,\n* Special dietary habits used by a small part of the population (veganism, low-carb hihg-fat diet, caloric restriction diet, note: vegetarians are not excluded)\n* Diets prescribed by the medical profession\n* Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases\n* Other diseases and conditions that affect the absorption and synthesis of vitamin D\n* Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium),\n* The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D,\n* Visiting the solarium in the last three months before joining the survey,\n* Mental incapacity that precludes adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT03818594', 'acronym': 'VITAD/1', 'briefTitle': 'Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Nutrition, Slovenia (Nutris)'}, 'officialTitle': 'Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1', 'orgStudyIdInfo': {'id': 'VITAD-01-2018 Part 1'}}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Nutrition Institute, Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Katja Žmitek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Researcher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Nutrition, Slovenia (Nutris)', 'class': 'OTHER'}, 'collaborators': [{'name': 'VIST - Faculty of Applied Sciences', 'class': 'OTHER'}, {'name': 'Slovenian Research Agency', 'class': 'OTHER'}, {'name': 'Valens Int. d.o.o., Slovenija', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}