Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-29 @ 4:00 AM
Study NCT ID:
NCT05598957
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein with Disease Severity in Pediatric Sars-CoV2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'to investigate the free and bioavailable vitamin D, 25OH vitamin d (μg/L), albumin (g/l) and VDBP levels, a 5 ml blood sample was collected from patients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The relationship between free vitamin D levels and SARS CoV-2 infection severity.', 'timeFrame': 'baseline (at the time of diagnosis)', 'description': 'The differences between free vitamin D levels in SARS CoV-2 infected patients according to the symptom severity. SARS CoV-2 infection severity will be categorized according to COVID19 WHO clinical progression Scale as uninfected, mild, moderate to severe.'}, {'measure': 'The relationship between bioavailable vitamin D levels and SARS CoV-2 infection severity.', 'timeFrame': 'baseline (at the time of diagnosis)', 'description': 'The differences between bioavailable vitamin D levels in SARS CoV-2 infected patients according to the symptom severity. SARS CoV-2 infection severity will be categorized according to COVID19 WHO clinical progression Scale as uninfected, mild, moderate to severe.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sars Cov-2', 'Vitamin D Binding protein', 'free vitamin D', 'bioavailable vitamin D', 'children'], 'conditions': ['SARS CoV-2 Infection']}, 'referencesModule': {'references': [{'pmid': '37888613', 'type': 'BACKGROUND', 'citation': 'Us MC, Devrim Lanpir A, Ozdatli Kurtulus S, Yagci M, Akarsu O, Sahin K, Akkoc G. The role of free vitamin D and vitamin D binding protein in SARS-Cov-2 infection in children. Pediatr Int. 2023 Jan-Dec;65(1):e15680. doi: 10.1111/ped.15680.'}, {'pmid': '7042881', 'type': 'BACKGROUND', 'citation': 'May JM. Triacylglycerol turnover in large and small rat adipocytes: effects of lipolytic stimulation, glucose, and insulin. J Lipid Res. 1982 Mar;23(3):428-36.'}, {'pmid': '8017947', 'type': 'BACKGROUND', 'citation': 'Alsina M, Martinez-Picado J, Jofre J, Blanch AR. A medium for presumptive identification of Vibrio anguillarum. Appl Environ Microbiol. 1994 May;60(5):1681-3. doi: 10.1128/aem.60.5.1681-1683.1994.'}, {'pmid': '34723751', 'type': 'BACKGROUND', 'citation': 'Speeckaert MM, Delanghe JR. Vitamin D binding protein and its polymorphisms may explain the link between vitamin D deficiency and COVID-19. Sci Prog. 2021 Oct;104(4):368504211053510. doi: 10.1177/00368504211053510. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'There were many studies in the literature discussing the effects of vitamin D deficiency and the role of vitamin D supplementation in SARS-CoV-2 patients. Combined with the possible impact of vitamin D on the pathogenesis of SARS-CoV-2 infection, it is concluded that VDBP-regulated bioavailable and free vitamin D concentrations modulate the human immune system response to viral infections. Because of the gap in the literature, it was emphasized that studies should focus on vitamin D binding protein (VDBP) and gene polymorphism. In this study, it was aimed to investigate the relationship between SARS-CoV-2 infection severity and free and bioavailable vitamin D levels.', 'detailedDescription': 'It was aimed to investigate the relationship between SARS-CoV-2 infection severity and free and bioavailable vitamin D levels. This study was planned as a case-control study with patients hospitalized in the Haseki Training and Research Hospital Pediatric Infection Service. A total of 82 children, including at least 20 patients in each group were included in the study. The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: unaffected (Group 1), mild (Group 2) and moderate (group 3). In order to investigate the relationship between disease severity and free and bioavailable vitamin D; 25OH vitamin d (μg/L), albumin (g/l) and VDBP levels (ELISA) were used. Vitamin D metabolites were calculated by using Bikle and Vermeulen methods (free Vitamin D BIKLE, free vitamin DVERMEULEN, bioavailable vitamin D). And these three vitamin D parameter levels were compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sars-CoV-2 diagnosed children aged between 1-18 years old and whose parents sign the informed consent form to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 1-18 years old,\n* Positive for SARS-CoV-2 PCR or positive for IgM in the SARS-CoV-2 antibody test (card test or ELISA),\n* Do not have a chronic disease (cystic fibrosis, etc.),\n* Volunteer to participate in the study.\n\nExclusion Criteria:\n\n* Being \\< 1 year of age'}, 'identificationModule': {'nctId': 'NCT05598957', 'briefTitle': 'Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein with Disease Severity in Pediatric Sars-CoV2', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein with Disease Severity in Pediatric Sars-CoV2', 'orgStudyIdInfo': {'id': '2022/10/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'uninfected Sars-CoV-2 group (Group 1)', 'description': 'The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: no viral RNA detected, uninfected Sars-CoV-2 patients (Group 1)', 'interventionNames': ['Diagnostic Test: Vitamin D Binding protein']}, {'label': 'mild Sars-CoV-2 group (Group 2)', 'description': 'The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: viral RNA detected but asymptomatic disease, ambulatory mild disease (Group 2)', 'interventionNames': ['Diagnostic Test: Vitamin D Binding protein']}, {'label': 'moderate to severe Sars-CoV-2 group (Group 3)', 'description': 'The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: hospitalized moderate disease, moderate to severe Sars-CoV-2 patients (group 3)', 'interventionNames': ['Diagnostic Test: Vitamin D Binding protein']}], 'interventions': [{'name': 'Vitamin D Binding protein', 'type': 'DIAGNOSTIC_TEST', 'description': 'Vitamin D-free and bioavailable metabolites were calculated by using Bikle and Vermeulen methods with using albumin, 25-OH vitamin D, vitamin D binding protein (ELİSA kit) levels', 'armGroupLabels': ['mild Sars-CoV-2 group (Group 2)', 'moderate to severe Sars-CoV-2 group (Group 3)', 'uninfected Sars-CoV-2 group (Group 1)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Haseki Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'mahmut caner US, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haseki Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'mahmut caner us', 'investigatorAffiliation': 'Marmara University'}}}}