Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-29 @ 4:24 AM
Study NCT ID:
NCT00031135
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2002-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Parenteral Nutrition-Associated Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002794', 'term': 'Choline'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-09'}, 'statusVerifiedDate': '2002-01', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2002-02-26', 'studyFirstSubmitQcDate': '2002-02-26', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-02-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Parenteral Nutrition, Total', 'Lipotropic Agents', 'Choline'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'This is a study to determine whether choline, when added to total parenteral nutrition (TPN), can help prevent the development of hepatic steatosis, a liver disease, in patients on TPN.', 'detailedDescription': "Choline deficiency-induced hepatic steatosis occurs in patients that require long-term TPN and may progress to significant hepatic disease and death. Initial studies indicate choline-supplemented TPN may reverse TPN-associated hepatic steatosis.\n\nCholine chloride or placebo will be added to each patient's TPN for 16 weeks by the hospital or pharmacy providing their usual TPN. Patients will receive their TPN in the hospital until they are medically stable for discharge. If patients are discharged before study completion, the pharmacy will deliver the TPN supply to them. Evaluation of hepatic steatosis is done by CT scans and blood analyses. Blood will be drawn on a biweekly basis during the first 4 weeks and at Week 8, 12, 16 or withdrawal. CT scans will be done at Week 4, 8, 16, or withdrawal.\n\nCompletion date provided represents the completion date of the grant per OOPD records"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome.\n* Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks.\n\nExclusion criteria:\n\n* Not receiving lipid emulsion with TPN regimen\n* Albumin less than 2.5 g/L\n* Renal failure requiring hemo- or peritoneal dialysis\n* Hepatic failure (PT greater than 2 times control)\n* Diabetes\n* Hepatitis C\n* AIDS\n* Concurrent hospitalization for organ transplantation or rejection treatment\n* Concurrent cholinergic medication\n* Positive pregnancy test\n* Refusal to use an acceptable method of birth control\n* Ethanol abuse\n* More than 40 kcal/kg/day ideal body weight\n* Obesity with ensuing weight loss\n* Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone'}, 'identificationModule': {'nctId': 'NCT00031135', 'briefTitle': 'Total Parenteral Nutrition-Associated Liver Disease', 'organization': {'class': 'FED', 'fullName': 'FDA Office of Orphan Products Development'}, 'officialTitle': 'Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'FD-R-1994-01'}, 'secondaryIdInfos': [{'id': 'FD-R-001994-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Choline Chloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}}}}