Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 7:07 PM
Study NCT ID:
NCT04920760
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin A Supplementation in Children With Moderate to Severe COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants, laboratory technicians, and statisticians will be blinded to the study arm allocation. Investigators and the ICU medical staff, however, will be unblinded due to the nature of intervention.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The current phase II, prospective, single-center, single-blinded, randomized placebo-controlled trial, will compare the standard care alone (as the control arm) or in combination with ˝vitamin A supplementation˝ (as the intervention arm) with an allocation ratio of 1:1 in a parallel-group design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-13', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality rate', 'timeFrame': 'within 28 days from end of intervention', 'description': 'COVID-19 mortality rate is defined as the number of deaths per 100 pediatric COVID-19 cases 28 days from the date of the intervention.'}], 'secondaryOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': 'on the day of hospital discharge', 'description': 'The length of hospital stay is defined as the difference between date of admission and date of discharge of the patient.'}, {'measure': 'length of pediatric intensive care unit (PICU) stay', 'timeFrame': 'on the day of PICU discharge', 'description': 'The length of PICU stay is defined as the difference between date of PICU admission and date of PICU discharge of the patient.'}, {'measure': 'length of intubation', 'timeFrame': 'on the day of extubation', 'description': 'The length of intubation is defined as the difference between date of beginning and end of intubation'}, {'measure': 'length of mechanical ventilation', 'timeFrame': 'the weaning time of mechanical ventilation', 'description': 'The length of mechanical ventilation is defined as the difference between date of beginning and end of mechanical ventilation.'}, {'measure': 'multiple organ involvement', 'timeFrame': 'on the day of the particular organ involvement', 'description': 'Multiple organ involvement is defined as one of either hematological, gastrointestinal, neurological, cardiovascular or hepatorenal complications.'}, {'measure': 'complete blood count (CBC)/diff', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Complete blood count with differential'}, {'measure': 'Prothrombin time (PT)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Prothrombin time'}, {'measure': 'Partial thromboplastin time (PTT)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Partial thromboplastin time'}, {'measure': 'International normalised ratio (INR)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'International normalised ratio'}, {'measure': 'fibrinogen', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'fibrinogen'}, {'measure': 'troponin', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'troponin'}, {'measure': 'Aspartate transaminase (AST)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Aspartate transaminase'}, {'measure': 'Alanine transaminase (ALT)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Alanine transaminase'}, {'measure': 'Blood urea nitrogen (BUN)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Blood urea nitrogen'}, {'measure': 'Cr', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Creatinine'}, {'measure': 'Erythrocyte sedimentation rate (ESR)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Erythrocyte sedimentation rate'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'C-reactive protein'}, {'measure': 'Lactate dehydrogenase (LDH)', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'Lactate dehydrogenase'}, {'measure': 'D-dimer', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'D-dimer'}, {'measure': 'ferritin', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'ferritin'}, {'measure': 'procalcitonin', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'procalcitonin'}, {'measure': 'vitamin A concentration', 'timeFrame': 'before and within 3 days from end of intervention', 'description': 'vitamin A concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin A', 'inflammation', 'pediatrics'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Severe acute respiratory syndrome (SARS)-like coronavirus 2 (Sars-CoV-2) pandemia is considered to be the current major global health issue. With no specific treatment or vaccine known to be licensed, empowering the immune system to overcome the inflammatory status associated with the late stages of the disease, particularly by anti-inflammatory nutrients, is of great concern.\n\nEffective in reducing both the morbidity and mortality of respiratory infections, including measles, vitamin A and its derivatives are reported to enhance the immune system and/or antibody response to virus vaccinations in children, particularly those with vitamin insufficiency. Retinoids are, therefore, proposed as an adjunct therapy in the treatment of COVID-19. The study is aimed to investigate the effects of vitamin A supplementation on disease improvement in pediatric and adolescent patients with either moderate or severe COVID-19 disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) aged between 1-month to 18-year old (boy or girl), 2) definitive or clinical diagnosis of severe acute respiratory syndrome (SARS)-like coronavirus 2 (SARS-COV-2) infection (by either a positive SARS-COV-2 polymerase chain reaction (PCR) test or a suggestive computed tomography (CT) scan, 3) no history or evidence of cancer or renal, hepatic, endocrine or viral disorders (including HIV/AIDS), 4) no history of supplementation either with vitamin A (VA) or with a multivitamin containing VA within the last 4 months, and 5) not participated in other clinical trials.\n\nExclusion Criteria:\n\n* 1\\) mildly infected with SARS-COV-2 virus, and 2) pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT04920760', 'briefTitle': 'Vitamin A Supplementation in Children With Moderate to Severe COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'The Effect of Vitamin A Supplementation on Disease Improvement of Children With Moderate to Severe COVID-19.', 'orgStudyIdInfo': {'id': '99-01-14-23475'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants receiving standard treatment alone.'}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin A', 'description': 'Participants receiving standard treatment with an additional vitamin A supplementation.', 'interventionNames': ['Dietary Supplement: Vitamin A supplement']}], 'interventions': [{'name': 'Vitamin A supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The supplementation protocol will be the additional care established by World Health Organization (WHO) and the United Nations International Children ʹs Fund (UNICEF) for measles (1998)(i.e. of 200,000 IU, or 50,000-100,000 IU for children \\> 1 or for infants of \\< 1 year of age, respectively).', 'armGroupLabels': ['Vitamin A']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Seyede Sedigheh Hamzavi, MD', 'role': 'CONTACT', 'email': 's.hamzavi55@yahoo.com', 'phone': '00989173626692'}, {'name': 'Seyede Maryam Abdollahzadeh, PhD', 'role': 'CONTACT', 'email': 'maryamabdh@gmail.com', 'phone': '00989173202131'}], 'overallOfficials': [{'name': 'Seyede Sedigheh Hamzavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Seyede Sedigheh Hamzavi', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}