Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 7:39 AM
Study NCT ID:
NCT03719092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2018-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}], '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': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, 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': 'D019984', 'term': 'Quality Indicators, Health Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance of Stool collection', 'timeFrame': 'Pre-transplant, day 0, day 14, and day 28', 'description': 'Compliance rate of take-home kit completion and inpatient stool collection'}, {'measure': 'Stool microbe and vitamin A correlation', 'timeFrame': 'Pre-transplant, day 0, day 14, and day 28', 'description': 'Correlation between stool microbes and response to vitamin A supplementation'}], 'primaryOutcomes': [{'measure': 'Vitamin A dose that achieves level in the upper quartile of normal range for sex in at least 2/3 cases without dose limiting toxicity', 'timeFrame': 'Up to day 28', 'description': 'Determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients.\n\ndetermining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients.'}], 'secondaryOutcomes': [{'measure': 'Incidence of gastrointestinal graft versus host disease', 'timeFrame': 'Up to day 180 after stem cell transplant', 'description': 'Cumulative incidence of GI GVHD will be calculated and graphed.'}, {'measure': 'Incidence of Toxicity', 'timeFrame': 'Up to 28 days', 'description': 'The toxicity analysis will include summarization of the toxicity and tolerability will be tabulated by dose level and summarized. Severe (grade 3+) toxicities will be summarized as well by type as well as in summary format of hematologic vs. non-hematologic severe toxicity incidence.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allogeneic Hematopoietic Stem Cell Transplantation Recipient']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This phase I trial studies the side effects and how well high dose vitamin A works in preventing gastrointestinal graft versus host disease (GVHD) in participants undergoing donor stem cell transplant. Vitamin A deficiency is associated with increased risk of gastrointestinal GVHD. Vitamin A regulates growth and differentiation of intestinal cells and may reduce risk of gastrointestinal GVHD.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. . To determine the biologically effective and tolerable dose (BETD) level of pretransplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients.\n\nSECONDARY OBJECTIVE:\n\nI. To evaluate the feasibility of collecting stool and profiling the gut microbiome in relation to Vitamin A.\n\nOUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 cohorts.\n\nTREATMENT COHORT: Patients receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant. Patients may receive vitamin A compound PO or enterally two weeks after stem cell transplant if vitamin A levels have not improved by at least 10%.\n\nCONTROL COHORT: Patients receive usual care.\n\nAfter completion of study treatment, participants are followed up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients planned to undergo an allogeneic stem cell transplant (SCT) with an human leukocyte antigen (HLA)-matched (unrelated or related) or 1 allele mismatched (7/8) donor or haploidentical donor who received either myeloablative or nonmyeloablative conditioning for hematologic malignancies are eligible\n\nExclusion Criteria:\n\n* Vitamin A hypersensitivity or allergy\n* Abnormal liver enzymes outside of the institutional laboratory normal range within 30 days of screening\n* Abnormal total, indirect, or direct bilirubin outside of the institutional laboratory normal range within 30 days of screening\n* Enteral feeding intolerance\n* Medication intolerance - history of allergic reaction to Vitamin A or other history of discontinuation to study drug due to adverse effect\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03719092', 'briefTitle': 'High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Single, High Dose Vitamin A Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'OSU-18078'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01838', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Cohort (vitamin A compound)', 'description': 'Participants receive vitamin A compound PO or enterally once prior to stem cell transplant.\n\nonce over a given 24 hour period with or without food. We will re-dose at 2000 IU/kg (maximum 120,000 IU) if Week 2 Vitamin A levels remain within 10% of baseline Vitamin A.', 'interventionNames': ['Dietary Supplement: Vitamin A Compound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Cohort (usual care)', 'description': 'Patients receive usual care.', 'interventionNames': ['Other: Best Practice']}], 'interventions': [{'name': 'Vitamin A Compound', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['A 313', 'Anti-Infective Vitamin', 'Antixerophthalmic Vitamin', 'Aquasol A', 'Arovit', 'Avibon', 'Avitol', 'Axerol', 'Axerophthol', 'Axerophtholum', 'Biosterol', 'Biovit-A', 'Del-Vi-A', 'Ido A 50', 'Idrurto A', 'Lard Factor', 'Lard-Factor', 'Ledovit A', 'Micelle A', 'Mulsal A Megadosis', 'Oleovitamin A', 'Ophthalamin', 'Pedi-Vit-A', 'Retinol, all trans-', 'Rinocusi Vitaminico', 'Vitamin A', 'Vitamin A Alcohol', 'Vitamin A USP', 'Vitamin A1', 'Vitaminoftalmina', 'Vitaminum A', 'Vogan'], 'description': 'Given PO or enterally', 'armGroupLabels': ['Treatment Cohort (vitamin A compound)']}, {'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['Standard of care', 'standard therapy'], 'description': 'Receive usual care', 'armGroupLabels': ['Control Cohort (usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Hannah Choe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hannah Choe, MD', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}