| Trial ID: | L1657 |
| Source ID: | NCT00561093
|
| Associated Drug: |
Pentoxiphylline
|
| Title: |
Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients
|
| Acronym: |
AIONID
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypoalbuminemia|Protein-energy Malnutrition|Inflammation|Oxidative Stress|Chronic Kidney Disease (CKD) Hemodialysis
|
| Interventions: |
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)
|
| Outcome Measures: |
Primary: Change in serum albumin, 16 weeks | Secondary: Changes in body composition and measures of nutrition, inflammation, anemia, Health related quality of life (HRQOL), and tolerance, 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Collaborators: DaVita Dialysis|Abbott Nutrition
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
93
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-02
|
| Completion Date: |
2011-05
|
| Results First Posted: |
|
| Last Update Posted: |
2015-05-21
|
| Locations: |
DaVita Nutrition Services, Irvine, California, 92618, United States|Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA, Torrance, California, 90502, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00561093
|
