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Total Parenteral Nutrition-Associated Liver Disease Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Total Parenteral Nutrition-Associated Liver Disease conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Total Parenteral Nutrition-Associated Liver Disease Clinical research trials and Total Parenteral Nutrition-Associated Liver Disease health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Total Parenteral Nutrition-Associated Liver Disease. Total Parenteral Nutrition-Associated Liver Disease Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Total Parenteral Nutrition-Associated Liver Disease clinical trial. Human subjects often get the best healthcare available for their Total Parenteral Nutrition-Associated Liver Disease condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Total Parenteral Nutrition-Associated Liver Disease  Total Parenteral Nutrition-Associated Liver Disease
Total Parenteral Nutrition-Associated Liver Disease
For Condition: Liver Diseases
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: 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.
Details: 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. Choline 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/74 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - 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. - Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks. Exclusion criteria: - Not receiving lipid emulsion with TPN regimen - Albumin less than 2.5 g/L - Renal failure requiring hemo- or peritoneal dialysis - Hepatic failure (PT greater than 2 times control) - Diabetes - Hepatitis C - AIDS - Concurrent hospitalization for organ transplantation or rejection treatment - Concurrent cholinergic medication - Positive pregnancy test - Refusal to use an acceptable method of birth control - Ethanol abuse - More than 40 kcal/kg/day ideal body weight - Obesity with ensuing weight loss - Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone
Total Enrollment: 48
Location and Contact Information:
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Alan Buchman 312-695-4514
Additional Information:
Study ID Numbers: FD-R-1994-01; FD-R-001994-01
Study Start Date: September 2001
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031135
Other Liver Diseases Studies:
1. Mechanisms of Inflammatory Liver Injury
2. Total Parenteral Nutrition-Associated Liver Disease
3. Delta Hepatitis and Liver Disease in Hemophiliacs
4. Hepatic Artery Infusion of CD34+ Cells
5. A Study of Zidovudine in HIV-Infected Patients with Liver Disease
Related Studies:
Other Liver Diseases Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Total Parenteral Nutrition-Associated Liver Disease
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