Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients

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

Conditions

• Hypoalbuminemia
• Protein-energy Malnutrition
• Inflammation
• Oxidative Stress
• Chronic Kidney Disease (CKD) Hemodialysis

Interventions

DRUG

pentoxiphylline

pentoxiphylline 400 mg daily, anti-inflammatory and appetite-stimulating while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

DIETARY_SUPPLEMENT

Nepro

Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

DIETARY_SUPPLEMENT

anti-inflammatory module (similar to Oxepa)

Oxepa-similar anti-inflammatory module (2 ounces) while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

DRUG

Placebo pill imitating pentoxiphylline

Placebo pill imitating pentoxiphylline 400 mg daily, to imitate the anti-inflammatory and appetite-stimulating pill while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

DIETARY_SUPPLEMENT

Placebo to imitate Nepro

Placebo to imitate Nepro (8 ounces), with less protein and calorie, one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

DIETARY_SUPPLEMENT

Placebo to imitate anti-inflammatory module (similar to Oxepa)

Placebo to imitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients, while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

Sponsors & Collaborators

• DaVita, Inc.

  collaborator INDUSTRY

• Abbott Nutrition

  collaborator INDUSTRY

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  lead OTHER

Principal Investigators

• Kamyar Kalantar-Zadeh, MD MPH PhD · LABioMed at Harbor-UCLA

• Arezu Dezfuli, MD · LABioMed at Harbor-UCLA

• Jennie Jing, MS · LABioMed at Harbor-UCLA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2010-10-31

Completion

2011-05-31

Countries

• United States

Study Locations