Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00852020
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2009-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2009-02-13', 'studyFirstSubmitQcDate': '2009-02-25', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compliance to nutrition therapy', 'timeFrame': 'baseline, months 1, 2, 3, 4'}], 'secondaryOutcomes': [{'measure': 'anorexia questionnaire', 'timeFrame': 'baseline, months 1, 2, 3, 4'}, {'measure': 'Gastrointestinal syndrome score (GIS)', 'timeFrame': 'baseline, months 1, 2, 3, 4'}, {'measure': 'body cell mass', 'timeFrame': 'baseline, months 1, 2, 3, 4'}, {'measure': 'weight change', 'timeFrame': 'baseline, months 1, 2, 3, 4'}, {'measure': 'hand grip strength', 'timeFrame': 'baseline, months 1, 2, 3, 4'}, {'measure': 'patient global assessment (PGA)', 'timeFrame': 'baseline, months 2, 4'}]}, 'conditionsModule': {'conditions': ['Cachexia', 'Chronic Obstructive Pulmonary Disease', 'Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of CHF or COPD\n* current body weight less than 6 months ago\n* BMI \\>=20 and \\<=30 kg/m2\n* CHF: LVEF \\>=45% measured within the past 6 months\n* symptom status equivalent to NYHA class II to IV\n* biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP\n* on standard therapy of CHF including ACE inhibitors and beta blockers\n* COPD: symptom status equivalent to GOLD standard class II to IV\n* FEV1 \\< 80%\n* FEV1/FEV \\< 70%\n\nExclusion Criteria:\n\n* significant oedema in the time of screening and randomisation\n* concomitant inflammatory diseases\n* active infections including HIV and AIDS\n* liver failure\n* chronic renal failure (sCr\\>1.5mg/dL) or cardiac pacemaker\n* acute or chronic infections\n* insulin treated diabetes mellitus\n* patient with established diagnosis of cachexia\n* life expectancy of less than 6 months in the opinion of the investigator\n* medications that impair sex hormone synthesis, secretion or function\n* patients with psychiatric diseases\n* body weight loss \\> 5% during the last 6 months or \\> 10% during the last 10 months\n* suspected allergy to any component of the investigational product(s)\n* fish oil supplementation within 3 months prior to the study entry\n* taking vitamin supplements in doses greater than the Recommended Daily Allowances'}, 'identificationModule': {'nctId': 'NCT00852020', 'briefTitle': 'Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.', 'orgStudyIdInfo': {'id': 'PCSU-002-CFS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants', 'interventionNames': ['Dietary Supplement: oral nutrition supplement, food for special medical purposes']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'oral nutritional supplement (isocaloric, isonitrogenous)', 'interventionNames': ['Dietary Supplement: oral nutrition supplement, food for special medical purposes']}], 'interventions': [{'name': 'oral nutrition supplement, food for special medical purposes', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 servings of 200-300 ml per day, treatment period: 16 weeks', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-16303', 'city': 'Schwedt', 'country': 'Germany', 'facility': 'Praxis für Pneumologie, Schwedt/Oder', 'geoPoint': {'lat': 53.05963, 'lon': 14.28154}}, {'zip': 'PL-41-940', 'city': 'Piekary Śląskie', 'country': 'Poland', 'facility': 'Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED', 'geoPoint': {'lat': 50.38017, 'lon': 18.92653}}, {'zip': 'PL-41-709', 'city': 'Ruda Śląska', 'country': 'Poland', 'facility': 'Specjalista Chorób Wewnętrznych Kardiolog', 'geoPoint': {'lat': 50.2584, 'lon': 18.85632}}], 'overallOfficials': [{'name': 'Stefan Anker, Prof. MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}