Inflammation Clinical Trial
— AIONIDOfficial 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
Verified date | May 2015 |
Source | Los Angeles Biomedical Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | USA: National Institutes of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 93 |
Est. completion date | May 2011 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | DaVita Nutrition Services | Irvine | California |
United States | Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Los Angeles Biomedical Research Institute | Abbott Nutrition, DaVita Dialysis |
United States,
Colman S, Bross R, Benner D, Chow J, Braglia A, Arzaghi J, Dennis J, Martinez L, Baldo DB, Agarwal V, Trundnowski T, Zitterkoph J, Martinez B, Khawar OS, Kalantar-Zadeh K. The Nutritional and Inflammatory Evaluation in Dialysis patients (NIED) study: overview of the NIED study and the role of dietitians. J Ren Nutr. 2005 Apr;15(2):231-43. Review. — View Citation
Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82. — View Citation
Kalantar-Zadeh K, Balakrishnan VS. The kidney disease wasting: inflammation, oxidative stress, and diet-gene interaction. Hemodial Int. 2006 Oct;10(4):315-25. Review. — View Citation
Kalantar-Zadeh K, Block G, McAllister CJ, Humphreys MH, Kopple JD. Appetite and inflammation, nutrition, anemia, and clinical outcome in hemodialysis patients. Am J Clin Nutr. 2004 Aug;80(2):299-307. — View Citation
Kalantar-Zadeh K, Braglia A, Chow J, Kwon O, Kuwae N, Colman S, Cockram DB, Kopple JD. An anti-inflammatory and antioxidant nutritional supplement for hypoalbuminemic hemodialysis patients: a pilot/feasibility study. J Ren Nutr. 2005 Jul;15(3):318-31. — View Citation
Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. Review. — View Citation
Kalantar-Zadeh K, Kilpatrick RD, Kuwae N, McAllister CJ, Alcorn H Jr, Kopple JD, Greenland S. Revisiting mortality predictability of serum albumin in the dialysis population: time dependency, longitudinal changes and population-attributable fraction. Nephrol Dial Transplant. 2005 Sep;20(9):1880-8. Epub 2005 Jun 14. — View Citation
Kalantar-Zadeh K, Stenvinkel P, Bross R, Khawar OS, Rammohan M, Colman S, Benner D. Kidney insufficiency and nutrient-based modulation of inflammation. Curr Opin Clin Nutr Metab Care. 2005 Jul;8(4):388-96. Review. — View Citation
Kalantar-Zadeh K. Recent advances in understanding the malnutrition-inflammation-cachexia syndrome in chronic kidney disease patients: What is next? Semin Dial. 2005 Sep-Oct;18(5):365-9. Review. — View Citation
Rammohan M, Kalantar-Zadeh K, Liang A, Ghossein C. Megestrol acetate in a moderate dose for the treatment of malnutrition-inflammation complex in maintenance dialysis patients. J Ren Nutr. 2005 Jul;15(3):345-55. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum albumin | 16 weeks | No | |
Secondary | Changes in body composition and measures of nutrition, inflammation, anemia, Health related quality of life (HRQOL), and tolerance | 16 weeks | Yes |
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