Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01326520
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2011-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dietary Phospholipids on 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in skin texture from baseline and in comparison with placebo', 'timeFrame': 'after 0,2,10,16, and 24 weeks', 'description': 'SCORAD Index'}], 'secondaryOutcomes': [{'measure': 'Immune status', 'timeFrame': 'after 0,2,10,16, and 24 weeks', 'description': 'total IgE, specific IgE, sE selectin, Interferon-gamma, Tumor necrosis factor-alpha, Interleukin 4, 12, 16, 31'}, {'measure': 'Lipid status', 'timeFrame': 'after 0,2,10,16, and 24 weeks', 'description': 'Blood lipids (Total cholesterol, LDL cholesterol, HDL cholesterol, triacyl glycerdies, fatty acids, phospholipids)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '24559855', 'type': 'DERIVED', 'citation': 'Keller S, Le HY, Rodiger C, Hipler UC, Kertscher R, Malarski A, Hunstock LM, Kiehntopf M, Kaatz M, Norgauer J, Jahreis G. Supplementation of a dairy drink enriched with milk phospholipids in patients with atopic dermatitis - a double-blind, placebo-controlled, randomized, cross-over study. Clin Nutr. 2014 Dec;33(6):1010-6. doi: 10.1016/j.clnu.2014.01.014. Epub 2014 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the influence of a milk phospholipid enriched dairy product on subjects with atopic dermatitis determining parameters of the immune status, the plasma lipid profile and the skin texture.', 'detailedDescription': 'Based on the facts, that on the one hand milk phospholipids are characterized by a high sphingolipid content and on the other hand a disturbed sphingolipid metabolism in the epidermis of patients with atopic dermatitis was verified, a double blinded, controlled, randomized, cross-over study with a daily supplementation of 3 g milk phospholipids to subjects with a mild to moderate atopic dermatitis will be conducted.\n\nForty patients will be randomized between two groups of each 20 patients. After an individual checkup and a run-in period of 2 weeks, the one group will receive the phospholipid enriched dairy product and the second group will be given a placebo dairy product over two month. A wash out-period of 4 weeks will follow, and the patients will consume the contrary dairy products over two month after a 2-week run-in period again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate atopic dermatitis (SCORAD \\< 30)\n* age: 18 - 60 years\n\nExclusion Criteria:\n\n* intolerance against milk proteins\n* systemic medication with corticosteroids or antihistamines\n* immune mediated disease\n* atherosclerosis\n* hyperlipidaemia\n* diabetes mellitus\n* angina pectoris\n* adipositas\n* pregnancy and breast feeding'}, 'identificationModule': {'nctId': 'NCT01326520', 'briefTitle': 'Effect of Dietary Phospholipids on Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Effect of Dietary Milk Phospholipids on Subjects With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'LSEP H49-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phospholipid enriched dairy product', 'interventionNames': ['Dietary Supplement: milk phospholipid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'dairy product', 'interventionNames': ['Dietary Supplement: diary product']}], 'interventions': [{'name': 'milk phospholipid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.', 'armGroupLabels': ['Phospholipid enriched dairy product']}, {'name': 'diary product', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The patients will consume daily 250 mL of a common dairy product.', 'armGroupLabels': ['dairy product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Friedrich Schiller University Jena, Department of Nutritonional Physiology', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Gerhard Jahreis, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich Schiller Univesity of Jena, Department of Nutritional Physiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Gerhard Jahreis', 'investigatorAffiliation': 'University of Jena'}}}}