Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-30 @ 12:40 AM
Study NCT ID:
NCT04127968
Status:
UNKNOWN
Last Update Posted:
2022-01-04
First Post:
2019-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014802', 'term': 'Vitamin A Deficiency'}, {'id': 'D018805', 'term': 'Sepsis'}], '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'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D009821', 'term': 'Oils'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-01', 'studyFirstSubmitDate': '2019-10-12', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': '2 years', 'description': 'The length of hospital stay will be measured by days'}], 'secondaryOutcomes': [{'measure': 'hospital mortality', 'timeFrame': '2 years', 'description': 'Hospital mortality will be record as ratio'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin A Deficiency', 'Pediatric', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '40843069', 'type': 'DERIVED', 'citation': 'Fu Q, Liu M, Zhang X, Fu J, Zhang G, Ji Y, Chen S. A randomized controlled trial on the efficacy and safety of vitamin A supplementation in children with sepsis. Front Pediatr. 2025 Aug 6;13:1579006. doi: 10.3389/fped.2025.1579006. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.', 'detailedDescription': 'It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '192 Months', 'minimumAge': '0 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age \\< 18 years,\n2. Expected to stay in the ICU for 48 hours or more,\n3. Vitamin A deficiency (VA \\< 0.2 mg/L)\n\nExclusion Criteria:\n\n1. Severely impaired gastrointestinal function\n2. Premature infants and low birth weight (LBW) infants\n3. Condition of underlying organ dysfunction\n4. Having received chemotherapy or radiotherapy\n5. Hematological malignancies\n6. Primary or acquired immunodeficiency'}, 'identificationModule': {'nctId': 'NCT04127968', 'briefTitle': 'Efficacy and Safety of Vitamin A Treatment for Children With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Efficacy and Safety of Vitamin A Treatment for Children With Sepsis: a Randomized Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '1010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Septic children with vitamin A deficiency who will receive vitamin A supplementation.', 'interventionNames': ['Drug: Vitamin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Septic children with vitamin A deficiency who will receive placebo.', 'interventionNames': ['Drug: Oil']}], 'interventions': [{'name': 'Vitamin A', 'type': 'DRUG', 'description': 'Children in intervention group will receive 50,000 IU vitamin A after being randomized.', 'armGroupLabels': ['intervention group']}, {'name': 'Oil', 'type': 'DRUG', 'description': 'Children in control group will receive equal volume of oil.', 'armGroupLabels': ['control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Yi Ji', 'investigatorAffiliation': 'West China Hospital'}}}}