Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT04949412
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2021-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Vitamin D Level in COVID-19
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D030181', 'term': 'Vitamin D Response Element'}], 'ancestors': [{'id': 'D020218', 'term': 'Response Elements'}, {'id': 'D004742', 'term': 'Enhancer Elements, Genetic'}, {'id': 'D012045', 'term': 'Regulatory Sequences, Nucleic Acid'}, {'id': 'D001483', 'term': 'Base Sequence'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D011401', 'term': 'Promoter Regions, Genetic'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D050436', 'term': 'Regulatory Elements, Transcriptional'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-01', 'studyFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum level of vitamin D in patients who infected with COVID19', 'timeFrame': 'during the period from the start of June 2021 to the end of July 2021'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin D', 'COVID-19', 'Severity'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Masoud HH, Zaky S, Baki AA. Management Protocol for COVID-19 Patients Version 1.4/30th May 2020 Ministry of health and population (MOHP), Egypt. 2020;(September)'}, {'pmid': '32603576', 'type': 'BACKGROUND', 'citation': 'Laird E, Rhodes J, Kenny RA. Vitamin D and Inflammation: Potential Implications for Severity of Covid-19. Ir Med J. 2020 May 7;113(5):81.'}, {'type': 'BACKGROUND', 'citation': 'Mohammed M, Shafik NS, Maher A, Hemdan SB, Elhamed MA. Liver Injuries in COVID-19 infected patients. Sohag Medical Journal. 2020;24(2):15-19.'}]}, 'descriptionModule': {'briefSummary': 'his a prospective observational study will be conducted on 100 patients who were diagnosed as SARS-CoV2 positive. The data will be collected from isolation hospital in Sohag governorate during the period from the start of June 2021 to the end of July 2021. Patients will be followed up for at least one month to evaluate the prognosis.', 'detailedDescription': "This a prospective observational study will be conducted on 100 patients who were diagnosed as SARS-CoV2 positive. The data will be collected from isolation hospital in Sohag governorate during the period from the start of June 2021 to the end of July 2021. Patients will be followed up for at least one month to evaluate the prognosis.\n\nInclusion criteria:\n\nPatients with SARS-CoV2 positive PCR.\n\nExclusion Criteria:\n\nPatients with chronic obstructive lung disease Chronic renal failure Patients with malabsorption Organ transplant recipient Pregnant women The study protocol will be approved by the scientific Research Ethical committee, Faculty of Medicine, Sohag University.\n\nThe Data will be collected after taken informed written consent from the patients:\n\nData about clinical manifestation including as fever, cough, dyspnea, fatigue and diarrhea.\n\nLaboratory investigation:\n\nCBC , liver function tests, CRP, D-dimer Serum creatinine, Random blood sugar, Serum ferritin and zwsVitamin D level\n\nAssessment the severity of the disease:\n\nPatients were classified into severe or mild cases based on results from chest radiography, clinical examination, and symptoms.\n\nPatients with mild symptoms (i.e., fever, cough, expectoration, and other upper respiratory tract symptoms), and without abnormalities, or with mild changes on chest radiography, were classified as non-severe types. A mild change in chest radiography is defined by multiple small patchy shadows and interstitial changes, mainly in the outer zone of the lung and under the pleura.\n\nSevere pneumonia was defined by the presence of any of the following conditions: i) significantly increased respiration rate (RR): RR ≥30 times/minute; ii) hypoxia: oxygen saturation (resting state) ≤93%; iii) blood gas analysis: partial pressure of oxygen/fraction of inspired oxygen (PaO2) /FiO2) ≤ 300 mmHg (millimeters of Mercury); or iv) the occurrence of respiratory or other organ failure that require Intensive care unit (ICU) monitoring and treatment, or shock 6.\n\nStatistical analysis:\n\nContinuous variables were expressed as mean ± standard deviation or median and interquartile range and compared with the student's t-test or Mann-Whitney U test according to the distribution of data. Categorical variables were presented as numbers and percentages and compared using the chi squared test or the Fisher exact test as appropriate. Spearman P rho was used to assess the relationships between serum 25OHD levels and several clinical and laboratory parameters. P value will be considered significant if it was less than 0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 patients who were diagnosed as SARS-CoV2 positive. The data will be collected from isolation hospital in Sohag governorate during the period from the start of June 2021 to the end of July 2021. Patients will be followed up for at least one month to evaluate the prognosis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with SARS-CoV2 positive PCR\n\nExclusion Criteria:\n\nPatients with chronic obstructive lung disease Chronic renal failure Patients with malabsorption Organ transplant recipient Pregnant women'}, 'identificationModule': {'nctId': 'NCT04949412', 'acronym': 'COVID19', 'briefTitle': 'Assessment of Vitamin D Level in COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Assessment of Serum Vitamin D Level in COVID-19 Infected Patients', 'orgStudyIdInfo': {'id': 'Soh-Med-21-06-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-severe COVID19', 'description': 'Patients with mild symptoms (i.e., fever, cough, expectoration, and other upper respiratory tract symptoms), and without abnormalities, or with mild changes on chest radiography, were classified as non-severe types or A mild change in chest radiography is defined by multiple small patchy shadows and interstitial changes, mainly in the outer zone of the lung and under the pleura.', 'interventionNames': ['Diagnostic Test: Vitamin D']}, {'label': 'Severe Covid19', 'description': 'Severe pneumonia was defined by the presence of any of the following conditions: i) significantly increased respiration rate (RR): RR ≥30 times/minute; ii) hypoxia: oxygen saturation (resting state) ≤93%; iii) blood gas analysis: partial pressure of oxygen/fraction of inspired oxygen (PaO2) /FiO2) ≤ 300 mmHg (millimeters of Mercury); or iv) the occurrence of respiratory or other organ failure that require Intensive care unit (ICU) monitoring and treatment, or shock', 'interventionNames': ['Diagnostic Test: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIAGNOSTIC_TEST', 'description': 'serum vitamin D level', 'armGroupLabels': ['Severe Covid19', 'non-severe COVID19']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Mona Mohammed Abdelrahman', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Mustafa Haridy, Deminstrator', 'role': 'STUDY_CHAIR', 'affiliation': 'Al-Azahar University'}, {'name': 'Mohamed Mahmoud, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}, {'name': 'Ahmed Nour-Eldin, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}, {'name': 'Asmaa Khalaf, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}, {'name': 'Amira Maher, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mona Mohammed Abdelrhman', 'investigatorFullName': 'Mona Mohammed Abdelrhman', 'investigatorAffiliation': 'Sohag University'}}}}