Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 11:35 AM
Study NCT ID:
NCT05008003
Status:
UNKNOWN
Last Update Posted:
2022-04-04
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vit D3 for Early Symptoms of 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': 'D059039', 'term': 'Standard of Care'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 Negativity by RT-PCR', 'timeFrame': 'From day 1 to day 14', 'description': 'The numbers of patients that tests COVID-19 negative'}, {'measure': 'COVID-19 symptoms improvement', 'timeFrame': 'From day 1 to day 14', 'description': 'The numbers of patients whose COVID-19 symptoms are subsided'}], 'secondaryOutcomes': [{'measure': 'Changes in CRP level', 'timeFrame': 'From day 1 to day 14', 'description': 'Improvement in blood CRP level'}, {'measure': 'Changes in D-dimer level', 'timeFrame': 'From day 1 to day 14', 'description': 'Improvement in blood D-dimer level'}, {'measure': 'Changes in LDH level', 'timeFrame': 'From day 1 to day 14', 'description': 'Improvement in blood LDH level'}, {'measure': 'Changes in ferritin level', 'timeFrame': 'From day 1 to day 14', 'description': 'Improvement in blood ferritin level'}, {'measure': 'Changes in full blood count', 'timeFrame': 'From day 1 to day 14', 'description': 'Improvement in full blood count'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This study is aimed to investigate the treatment vitamin D3 as complementary therapy with routine care for early mild symptoms of COVID-19 in outpatients setting.', 'detailedDescription': 'There is currently no specific early-stage therapeutic treatment available for COVID-19.\n\nVitamin D3 is a strong antioxidant, and anti-inflammatory/immunomodulatory agent.\n\nThe present study is aimed to investigate the treatment benefits of vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 18 years of age or older, of either gender\n* Patients must be tested positive for SARS-CoV-2 by RT-PCR\n* Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.\n* Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening\n* Patients must be under the care of a Physician for diagnosis of COVID-19\n* Patients who have signed informed consent\n\nExclusion Criteria:\n\n* Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin\n* Patients with known chronic kidney disease with estimated creatinine clearance \\< 50 mL/minute or need for dialysis\n* Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure\n* Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.\n* Patients with gallstone obstruction\n* Hypothyroid suppering patients\n* Patients with moderate or severe thrombocytopenia (platelet count \\<100 ×10⁹/L);\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT05008003', 'briefTitle': 'Vit D3 for Early Symptoms of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Ayub Teaching Hospital'}, 'officialTitle': 'Vit D3 Adjuvant Therapy for Early Mild Symptoms of COVID-19', 'orgStudyIdInfo': {'id': 'CQC/COVID/08-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'This arm will receive the standard of care as per the hospital guidelines.', 'interventionNames': ['Drug: Standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'Investigational treatment', 'description': 'This arm will receive vitamin D3 supplement as add-on to the standard of care.', 'interventionNames': ['Drug: Standard of care', 'Dietary Supplement: Vitamin D3']}], 'interventions': [{'name': 'Standard of care', 'type': 'DRUG', 'description': 'Standard of care treatment as per the hospital guidelines', 'armGroupLabels': ['Investigational treatment', 'Standard of care']}, {'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily dose of 5000 IU vitamin D3 for 7 days.', 'armGroupLabels': ['Investigational treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22010', 'city': 'Abbottabad', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'contacts': [{'name': 'Dr. Zeeshan Haroon, MBBS', 'role': 'CONTACT', 'email': 'zeeshanharoon@yahoo.com', 'phone': '+ 92 317 5564317'}], 'facility': 'Ayub Teaching Hospital', 'geoPoint': {'lat': 34.1463, 'lon': 73.21168}}], 'centralContacts': [{'name': 'Dr. Zeeshan Haroon, MBBS', 'role': 'CONTACT', 'email': 'zeeshanharoon@yahoo.com', 'phone': '+ 92 317 5564317'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayub Teaching Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Liaquat University of Medical & Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Community Medicine', 'investigatorFullName': 'Dr Umer Farooq', 'investigatorAffiliation': 'Ayub Teaching Hospital'}}}}