Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06098820
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of UV-C Enriched Foods on Vitamin D Deficiency
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Forty-eight people aged 18-65 years with serum 25(OH)vitamin D levels below 30 μg/L and who meet the study criteria will be selected for the study. Four groups, 12 per group, will be randomly selected by computer-assisted randomization.\n\nGroup 1 (UV-C mushroom+normal bread group):\n\nGroup 2 (UV-C mushroom + UV-C bread group) Group 3 (normal mushroom + normal bread group) Group 4 (normal mushroom + normal bread + supplement group)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D values', 'timeFrame': 'Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention', 'description': 'During study, Vitamin D values are evaluated.'}, {'measure': 'Biochemical parameters', 'timeFrame': 'Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention', 'description': 'Ca and parathormone are evaluated during the study.'}, {'measure': 'Demographic parameters', 'timeFrame': 'Pre-intervention', 'description': 'Demographic values (age, gender, etc.) are also investigated.'}, {'measure': 'Food consumption record', 'timeFrame': 'Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention', 'description': 'Before starting the study and after the end of study the food consumption of participants are evaluated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin d Deficiency']}, 'descriptionModule': {'briefSummary': 'This study is an experimental design study in which demographic characteristics, food consumption, biochemical parameters and anthropometric measurements of individuals with low vitamin D levels before and after consuming UV-enriched foods will be examined.', 'detailedDescription': 'It was designed to be applied to individuals with low vitamin D levels working in Fatih Sultan Mehmet Training and Research Hospital who meet the research conditions.\n\nn the first phase of the study, demographic information will be recorded by asking demographic information from the people who volunteered to participate in the study and who meet the study criteria by using a questionnaire form and 3-day food consumption record information by face-to-face interview technique; anthropometric measurements of the participants will be taken and baseline blood values will be recorded. At the beginning of the experimental study, individuals will be randomized by computer-assisted randomization into four different groups. Biochemical analyses will be analyzed every two weeks, analyses will be repeated 1 month after the study and the effects of vitamin D enrichment on biochemical parameters will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Working in the hospital\n2. Being between the ages of 18 and 65\n3. Not being pregnant or lactating\n4. Not taking vitamin D supplements or fish oil in the last 1 month\n5. Serum 25(OH)vitamin D value below 30 μg/L\n6. No kidney disease, kidney stones, cortisone use, blood thinners\n7. Not being in a solarium\n8. Not eating fish more than once a week\n9. Volunteering to participate in the research\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT06098820', 'briefTitle': 'The Effect of UV-C Enriched Foods on Vitamin D Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Okan University'}, 'officialTitle': 'The Effect of Consumption of UV-C Enriched Foods on Biochemical Findings in Adults With Vitamin D Deficiency', 'orgStudyIdInfo': {'id': '2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (UV-C mushroom+normal bread group)', 'description': 'UV-C mushroom+normal bread group', 'interventionNames': ['Other: Vitamin D status']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (UV-C mushroom + UV-C bread group)', 'description': 'UV-C mushroom + UV-C bread group', 'interventionNames': ['Other: Vitamin D status']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (normal mushroom + normal bread group)', 'description': 'normal mushroom + normal bread group', 'interventionNames': ['Other: Vitamin D status']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 (normal mushroom+normal bread+supplemente group)', 'description': 'normal mushroom + normal bread + supplement group', 'interventionNames': ['Other: Vitamin D status']}], 'interventions': [{'name': 'Vitamin D status', 'type': 'OTHER', 'description': 'Four different groups will be compared with each other in terms of vitamin D effect.', 'armGroupLabels': ['Group 1 (UV-C mushroom+normal bread group)', 'Group 2 (UV-C mushroom + UV-C bread group)', 'Group 3 (normal mushroom + normal bread group)', 'Group 4 (normal mushroom+normal bread+supplemente group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'OkanU', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arçelik A.Ş.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Aylin Seylam Küşümler', 'investigatorAffiliation': 'Okan University'}}}}