Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients (AIONID)
This study has been completed.
Sponsor:
Los Angeles Biomedical Research Institute
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
|
|
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 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:
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:
|
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
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 Hypoalbuminemia Renal Insufficiency, Chronic Kidney Failure, Chronic Pathologic Processes Urologic Diseases Protein Deficiency Deficiency Diseases Nutrition Disorders 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 |
ClinicalTrials.gov processed this record on May 21, 2013