Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-28 @ 2:23 AM
Study NCT ID:
NCT00687050
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2008-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2008-05-27', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cross sectional area of triceps m. in mid-humerus position (MRT)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'plasma albumin < 3.6 mg/dl', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['end-stage renal disease', 'chronic kidney disease'], 'conditions': ['End-Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '29146139', 'type': 'DERIVED', 'citation': 'Zilles M, Betz C, Jung O, Gauer S, Hammerstingl R, Wachtershauser A, Vogl TJ, Geiger H, Asbe-Vollkopf A, Pliquett RU. How to Prevent Renal Cachexia? A Clinical Randomized Pilot Study Testing Oral Supplemental Nutrition in Hemodialysis Patients With and Without Human Immunodeficiency Virus Infection. J Ren Nutr. 2018 Jan;28(1):37-44. doi: 10.1053/j.jrn.2017.07.003. Epub 2017 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic changes or both. Human immunodeficiency virus-infection may exacerbate the state of malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition. The nutritional state will be determined in magnet resonance tomography at the start and at the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV patients. This pilot study may lead to larger randomized clinical trials and, may affect dietary recommendations.', 'detailedDescription': 'In end-stage renal disease (ESRD), cachexia is a common finding. Metabolic changes, malnutrition, or both appear to be the underlying problems. In fact, lean body mass per body weight better predicts prognosis than creatinin based models (NDT, 2004.19:1182). In addition, comorbidity such as HIV infection may exacerbate cachexia found in ESRD. Whether or not daily supplemental, high-caloric nutrition in ESRD corrects a catabolic state in ESRD is unclear.\n\nHypothesis to be tested:\n\nDaily supplemental high-caloric nutrition beneficially affects cytokine stimulation (TNF alpha, IL 1beta, IL 6, CrP) and nutritional state (cross sectional area of triceps m. in mid-humerus position (MRT), plasma albumin) in in HIV-positive hemodialysis patients and in chronic hemodialysis patients compared to chronic hemodialysis patients without supplemental nutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients on hemodialysis for more than 1 year,\n* Group 1: HIV infection\n\nExclusion Criteria:\n\n* patients on hemodialysis for less than 1 year,\n* Group 2 and 3: HIV infection\n* no pre-/post dialysis weight differences of \\> 3 kg after long HD free interval over last 10 HD sessions.\n* no current high-caloric nutrition supplements or planned high-caloric supplements for clinical reasons.\n* pregnancy\n* for women: no use of oral contraceptives or other at least equally effective contraception in women with childbearing potential\n* known neoplastic disease other than skin tumors (except melanoma)\n* mental disease or retardation with impaired judgement power'}, 'identificationModule': {'nctId': 'NCT00687050', 'briefTitle': 'Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'MRT-based Pilot Study to Evaluate Peroral Supplemental Nutrition for Prevention of Cachexia in End-stage Renal Disease With and Without HIV Comorbidity', 'orgStudyIdInfo': {'id': 'Goethe-Uni-FFM-328-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'HIV-positive hemodialysis patients (as a high risk group for cachexia) will be given daily drinks of Renilon 7.5 (125 ml, 2 kcal/ml) as peroral supplemental nutrition on top to their recommended high-protein, high-caloric diet.', 'interventionNames': ['Dietary Supplement: peroral high-caloric supplemental nutrition']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Chronic hemodialysis patients randomized to no peroral supplemental nutrition'}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Chronic hemodialysis patients randomized to peroral supplemental nutrition.', 'interventionNames': ['Dietary Supplement: peroral supplemental nutrition']}], 'interventions': [{'name': 'peroral high-caloric supplemental nutrition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Renilon 7.5 by Pfrimmer Nutricia'], 'description': 'HIV-positive hemodialysis patients will be given daily supplemental nutrition (125 ml, 2 kcal/ml) on top of recommended high-protein, high-caloric regular diet', 'armGroupLabels': ['1']}, {'name': 'peroral supplemental nutrition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Renilon 7.5 by Pfrimmer-Nutricia'], 'description': 'Chronic hemodialysis patients will be given daily peroral supplemental nutrition (125 ml/d, 2 kcal/ml) on top of their recommended high-protein, high caloric diet', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Hospital of the Goethe University Frankfurt am Main', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfrimmer Nutricia GmbH, Erlangen , Germany', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Rainer U. Pliquett', 'oldOrganization': 'Goethe University Frankfurt am Main'}}}}