Clinical Trial: Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pilot/Feasibility Randomized Control Trial to Examine the Effect of Oral Nutritional Supplements With Anti-inflammatory/Anti-oxidative Properties and Pentoxiphylline on Malnutrition-inflammation-cache

Brief Summary: Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and antioxidative properties combined with an appetite stimulant with anti-inflammatory properties (pentoxiphylline) in treatment of malnutrition-inflammation-cachexia syndrome in maintenance hemodialysis patients

Detailed Summary:

There are 350,000 hemodialysis patients in the USA; these are people who have end-stage kiney disease and whose survival depends on thrice weekly hemodialysis treatment in a dialysis clinic. Hemodialysis patients have an unacceptably high death rate, so that one out of every 4 to 5 patients die each year. Almost half of all deaths are believed to be from heart disease. Because markers of malnutrition and inflammation such as low amount of blood protein (serum albumin <4.0 g/dL), rather than traditional risk factors, are among the strongest predictors of early death and because malnutrition-inflammation appears to be closely related to oxidative stress in hemodialysis patients, we would like to examine that hypotesis that treating malnutrition-inflammation-oxidation by mean of nutritional support may improve outcomes in them. Low serum albumin <4.0 g/dL is observed in almost half of all hemodialysis patients and appears associated with low appetite, wasting, inflammation, malfunction of the vessels, cardiovascular disease and several fold increase in mortality.

We hypothesize that the malnutrition-inflammation can be significantly corrected by a simple in-center oral nutritional support with anti-inflammatory and antioxidant properties combined with an appetite stimulant with anti-inflammatory properties, leading to improved clinical and nutritional outcome measures in hemodialysis patients. We have proposed to the National Institutes of Health a pilot/feasibility study where dialysis patients will have 50-50 chance of receiving real treatment or a fake version of it (placebo). This method is called randomization, and this study type is called "randomized placebo-controlled clinical trial" with two arms, a so-called 2x2 factorial design. Our proposed study has a low-priced but efficient operational system and will be performed in 8 to 10 DaVita dialysis cli
Sponsor: Los Angeles Biomedical Research Institute

Current Primary Outcome: Change in serum albumin [ Time Frame: 16 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in body composition and measures of nutrition, inflammation, anemia, Health related quality of life (HRQOL), and tolerance [ Time Frame: 16 weeks ]

Original Secondary Outcome: Changes in body composition and measures of nutrition, inflammation, anemia and Health related quality of life (HRQOL) [ Time Frame: 16 weeks ]

Information By: Los Angeles Biomedical Research Institute

Dates:
Date Received: November 19, 2007
Date Started: February 2008
Date Completion:
Last Updated: May 20, 2015
Last Verified: May 2015