Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients (AIONID)
Hypoalbuminemia, Protein-energy Malnutrition, Inflammation
About this trial
This is an interventional treatment trial for Hypoalbuminemia focused on measuring Hypoalbuminemia, Protein-energy malnutrition, Inflammation, Oxidative stress, Chronic Kidney disease (CKD) stage 5, maintenance hemodialysis
Eligibility 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.
Sites / Locations
- DaVita Nutrition Services
- Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
A
B
C
D
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)
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)
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)
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)