Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-08 @ 1:06 AM
Study NCT ID:
NCT03117660
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Retinoids on CYP2D6 Activity During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014801', 'term': 'Vitamin A'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, parallel group study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-12', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CYP2D6 activity: dextromethorphan metabolic ratio', 'timeFrame': '4 weeks', 'description': 'dextromethorphan metabolic ratio change from baseline during pregnancy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CYP2D6 Polymorphism']}, 'referencesModule': {'references': [{'pmid': '33069736', 'type': 'BACKGROUND', 'citation': 'Somani ST, Zeigler M, Fay EE, Leahy M, Bermudez B, Totah RA, Hebert MF. Changes in erythrocyte membrane epoxyeicosatrienoic, dihydroxyeicosatrienoic, and hydroxyeicosatetraenoic acids during pregnancy. Life Sci. 2021 Jan 1;264:118590. doi: 10.1016/j.lfs.2020.118590. Epub 2020 Oct 15.'}, {'pmid': '36309846', 'type': 'BACKGROUND', 'citation': 'Amaeze OU, Czuba LC, Yadav AS, Fay EE, LaFrance J, Shum S, Moreni SL, Mao J, Huang W, Isoherranen N, Hebert MF. Impact of Pregnancy and Vitamin A Supplementation on CYP2D6 Activity. J Clin Pharmacol. 2023 Mar;63(3):363-372. doi: 10.1002/jcph.2169. Epub 2022 Nov 15.'}, {'pmid': '35405978', 'type': 'BACKGROUND', 'citation': 'Czuba LC, Fay EE, LaFrance J, Smith CK, Shum S, Moreni SL, Mao J, Isoherranen N, Hebert MF. Plasma Retinoid Concentrations Are Altered in Pregnant Women. Nutrients. 2022 Mar 25;14(7):1365. doi: 10.3390/nu14071365.'}]}, 'descriptionModule': {'briefSummary': 'Prospective drug interaction study during pregnancy.', 'detailedDescription': 'A randomized pharmacokinetic study to evaluate CYP2D6 activity with and without vitamin A administration during pregnancy and compared to postpartum control.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnancy study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies\n* Extensive metabolizers\n\nExclusion Criteria:\n\n* Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease\n* Productive cough\n* Fever\n* Known kidney disease\n* Known liver disease\n* Diabetes\n* Obesity\n* Bipolar disease\n* Attention deficit disorder\n* Social phobia\n* Allergy or history of adverse event with dextromethorphan\n* Drugs, foods, beverages or dietary supplements that interact with CYP2D6 or dextromethorphan\n* dextromethorphan\n* Unable to give written informed consent\n* Inability to fast\n* Concurrent use of vitamin A supplementation'}, 'identificationModule': {'nctId': 'NCT03117660', 'briefTitle': 'Effects of Retinoids on CYP2D6 Activity During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations', 'orgStudyIdInfo': {'id': 'STUDY00001620'}, 'secondaryIdInfos': [{'id': 'R01GM124264-01', 'link': 'https://reporter.nih.gov/quickSearch/R01GM124264-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin A', 'description': 'Subjects will receive 3-4weeks of vitamin A', 'interventionNames': ['Drug: Vitamin A']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects will receive no treatment'}], 'interventions': [{'name': 'Vitamin A', 'type': 'DRUG', 'description': 'vitamin A daily X3-4 weeks', 'armGroupLabels': ['Vitamin A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Mary F Hebert, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The investigators will adhere to the NIH Grant Policy on Sharing Research Data. That is, after final data collection and analysis and after full peer review is performed on the data, the de-identified data generated by this project will be made available when requested by the academic community and researchers-at-large contingent upon Material Transfer Agreements with the University of Washington.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Mary Hebert', 'investigatorAffiliation': 'University of Washington'}}}}