Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02103556
Status:
COMPLETED
Last Update Posted:
2014-04-04
First Post:
2014-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Edible Oils in the Treatment of Constipation of Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008899', 'term': 'Mineral Oil'}, {'id': 'D000069463', 'term': 'Olive Oil'}, {'id': 'D008043', 'term': 'Linseed Oil'}], 'ancestors': [{'id': 'D010577', 'term': 'Petrolatum'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-01', 'studyFirstSubmitDate': '2014-03-10', 'studyFirstSubmitQcDate': '2014-04-01', 'lastUpdatePostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of constipation symptoms', 'timeFrame': '1 month', 'description': 'Constipation was diagnosed by the Rome III criterion. The diagnosis consists in the presence, for at least three months, of two or more of the following symptoms: "fewer than three evacuations per week", "straining on evacuation", "lumpy or hard stools", "incomplete evacuation", "anorectal obstruction" and use of "manual maneuvers" to facilitate evacuation. Each symptom is scored as: 0=never or rarely, 1=sometimes, 2=often, 3=most of the time and 4=always. In the present study, the frequency of the symptoms was considered as a continuous variable and, a final score ranging from 0 to 24 was calculated. Lowest scores were indicative of fewer symptoms of constipation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Constipation', 'Rome III criteria', 'Hemodialysis'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the effect of olive oil and flaxseed oil in the treatment of constipation of patients undergoing hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Constipated patients by Rome III criteria\n* Hemodialysis \\> 3 months\n\nExclusion Criteria:\n\n* Diagnosis of gastrointestinal disease other than constipation\n* Previous intolerance to the oils used in the study\n* Cognitive limitations'}, 'identificationModule': {'nctId': 'NCT02103556', 'briefTitle': 'Edible Oils in the Treatment of Constipation of Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Double-blind Randomized Trial on the Effect of Olive Oil and Flaxseed Oil on Constipation of Hemodialysis Patients', 'orgStudyIdInfo': {'id': '2012/06605-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mineral oil', 'description': '4ml daily (adjusted as needed), for 4 weeks', 'interventionNames': ['Other: Mineral oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olive oil', 'description': '4ml daily (adjusted as needed), for 4 weeks', 'interventionNames': ['Dietary Supplement: Olive oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flaxseed oil', 'description': '4 ml daily (adjusted as needed), for 4 weeks', 'interventionNames': ['Dietary Supplement: Flaxseed oil']}], 'interventions': [{'name': 'Mineral oil', 'type': 'OTHER', 'description': '4 ml daily (adjusted as needed), for 4 weeks', 'armGroupLabels': ['Mineral oil']}, {'name': 'Olive oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 ml daily (adjusted as needed), for 4 weeks', 'armGroupLabels': ['Olive oil']}, {'name': 'Flaxseed oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 ml daily (adjusted as needed), for 4 weeks', 'armGroupLabels': ['Flaxseed oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04039-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Lilian Cuppari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Christiane I Ramos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Affiliate Professor', 'investigatorFullName': 'Lilian Cuppari', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}