Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-30 @ 9:32 AM
Study NCT ID:
NCT01936194
Status:
WITHDRAWN
Last Update Posted:
2016-09-16
First Post:
2013-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Polyunsaturated Fatty Acids (PUFA) on Allergic/Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "Investigators don't want to conduct this study as time is limited.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-09-02', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid Analysis', 'timeFrame': 'Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum'}, {'measure': 'Metabolomics Study of PUFA', 'timeFrame': 'Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum'}, {'measure': 'Skin Prick Test to Common Allergens', 'timeFrame': '4 months postpartum, 12 months postpartum'}, {'measure': 'Clinical Assessment of IgE-mediated Allergic Eczema', 'timeFrame': '4 months postpartum, 12 months postpartum'}], 'secondaryOutcomes': [{'measure': 'Fatty Acid Desaturase (FADS) Genotypes', 'timeFrame': 'Baseline'}, {'measure': 'immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies', 'timeFrame': 'Baseline'}, {'measure': 'Immunological Biomarkers', 'timeFrame': '4 months postpartum, 12 months postpartum'}, {'measure': 'Medically-confirmed adverse events collected throughout the study period', 'timeFrame': '12 months postpartum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman is pregnant between 16 and 20 weeks\n* Mother delivers after 36 weeks\n* Mother is willing to breast-feed for four months\n* Mother has potential to deliver a child with increased risk of atopic dermatitis\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Mother is smoking\n* Disease with influence on breast feeding\n* Complicated pregnancy\n* Allergic to seafood\n* Allergic to soy\n* Allergic to marine fish\n* Mother has more than two salmon or tuna meals per week\n* Mother is undergoing treatment with anticoagulants'}, 'identificationModule': {'nctId': 'NCT01936194', 'briefTitle': 'The Effects of Polyunsaturated Fatty Acids (PUFA) on Allergic/Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis', 'orgStudyIdInfo': {'id': '6018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docosahexaenoic Acid (DHA)', 'description': 'infants receiving capsule containing DHA.', 'interventionNames': ['Dietary Supplement: DHA']}, {'type': 'OTHER', 'label': 'High Olive Oil', 'description': 'infants receiving capsule without DHA and EPA.', 'interventionNames': ['Dietary Supplement: High Olive Oil']}, {'type': 'EXPERIMENTAL', 'label': 'DHA+EPA', 'description': 'infants receiving capsule containing DHA and EPA.', 'interventionNames': ['Dietary Supplement: DHA+EPA']}], 'interventions': [{'name': 'DHA+EPA', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['DHA+EPA']}, {'name': 'High Olive Oil', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['High Olive Oil']}, {'name': 'DHA', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Docosahexaenoic Acid (DHA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'International Peace Maternity and Child Health Hospital of China welfare Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhiwei Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Peace Maternity and Child Health Hospital of China Welfare Institution'}, {'name': 'Huiyong Yin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Sciences'}, {'name': 'Bryan Liu, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson & Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'International Peace Maternity and Child Health Hospital', 'class': 'OTHER'}, {'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}