Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients (AIONID)

This study has been completed.
Sponsor:
Collaborators:
DaVita Dialysis
Abbott Nutrition
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00561093
First received: November 19, 2007
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Hypoalbuminemia
Protein-energy Malnutrition
Inflammation
Oxidative Stress
Chronic Kidney Disease (CKD) Hemodialysis
Drug: pentoxiphylline
Dietary Supplement: Nepro
Dietary Supplement: anti-inflammatory module (similar to Oxepa)
Drug: Placebo pill imitating pentoxiphylline
Dietary Supplement: Placebo to imitate Nepro
Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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-cachexia Syndrome in Maintenance Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • Change in serum albumin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in body composition and measures of nutrition, inflammation, anemia, Health related quality of life (HRQOL), and tolerance [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: February 2008
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Group A (n=25) Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ounces) AND pentoxiphylline (400 mg) while undergoing hemodialysis and the following non-dialysis day (6 days per week)
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)
Other Name: Trental, 400 mg pills
Dietary Supplement: Nepro
Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
Other Name: Nepro with Carb ™ Steady
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)
Other Name: Oxepa-similar anti-inflammatory module (2 ounces)
Experimental: B
Group B (n=25) Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ounces) AND Placebo to imitate pentoxiphylline while undergoing hemodialysis and 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)
Other Name: Nepro with Carb ™ Steady
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)
Other Name: Oxepa-similar anti-inflammatory module (2 ounces)
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)
Other Names:
  • 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)
Experimental: C
Group C (n=25) Placebo dietary supplement to imitate Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ounces) AND pentoxiphylline (400 mg) while undergoing hemodialysis and the following non-dialysis day (6 days per week)
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)
Other Name: Trental, 400 mg pills
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)
Other Name: Placebo to imitate Nepro (8 ounces), with less protein and calorie,
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)
Other Names:
  • Placebo to immitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients,
  • 0011084880
Placebo Comparator: D
Group D (n=25) Placebo to imitate Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ounces) AND Placebo to imitate pentoxiphylline (400 mg) while undergoing hemodialysis and 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)
Other Names:
  • 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)
Other Name: Placebo to imitate Nepro (8 ounces), with less protein and calorie,
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)
Other Names:
  • Placebo to immitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients,
  • 0011084880

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 3 months on maintenance hemodialysis,
  • Last 3-month averaged serum albumin <4.0 g/dl,
  • Average monthly Kt/V>1.2,
  • Dialysis time between 3 and 5 hours,
  • Functioning AV graft or fistula or tunnel catheter that will not switch for 6 months,
  • Standardized dialysis treatment per DaVita protocol.
  • In case the averaged 3-month is not <4.0 g/dl but last month serum albumin <4.0 g/dl (worsening hypoalbuminemia) patient will be qualified, if 3-month averaged nPNA < 0.8 g/kg/day or a BMI < 20 kg/m2.

Exclusion Criteria:

  • Peritoneal dialysis
  • Terminal illnesses with life expectancy<6 months
  • Maintenance hemodialysis less than 5 months
  • Concurrent appetite stimulants
  • Use of IDPN in the past 2-3 months
  • Inability to follow and to comply with the instructions and guidelines
  • Likelihood of pregnancy or intention to become pregnant
  • Acute wasting condition or active systemic disease
  • Pulse chemo therapy
  • Non-compliance with dialysis treatment
  • Dialysis catheter that may switch soon.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561093

Locations
United States, California
DaVita Nutrition Services
Irvine, California, United States, 92618
Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
DaVita Dialysis
Abbott Nutrition
Investigators
Principal Investigator: Kamyar Kalantar-Zadeh, MD MPH PhD LABioMed at Harbor-UCLA
Study Director: Arezu Dezfuli, MD LABioMed at Harbor-UCLA
Study Director: Jennie Jing, MS LABioMed at Harbor-UCLA
  More Information

Additional Information:
Publications:

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00561093     History of Changes
Other Study ID Numbers: R21 DK78012 (completed), Harbor-UCLA LABioMed # 12630
Study First Received: November 19, 2007
Last Updated: April 15, 2013
Health Authority: United States: National Institutes of Health

Keywords provided by Los Angeles Biomedical Research Institute:
Hypoalbuminemia
Protein-energy malnutrition
Inflammation
Oxidative stress
Chronic Kidney disease (CKD) stage 5
maintenance hemodialysis

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Protein-Energy Malnutrition
Malnutrition
Nutrition Disorders
Hypoalbuminemia
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases
Protein Deficiency
Deficiency Diseases
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases
Renal Insufficiency
Anti-Inflammatory Agents
Contraceptives, Oral
Pentoxifylline
Therapeutic Uses
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Radiation-Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014