| Trial ID: | L0968 |
| Source ID: | NCT00237718
|
| Associated Drug: |
Alpha, Gamma, Beta, And Delta (Mixed) Tocopherols
|
| Title: |
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00237718/results
|
| Conditions: |
End-stage Renal Disease
|
| Interventions: |
DRUG: Alpha, gamma, beta, and delta (mixed) tocopherols|DRUG: Alpha lipoic acid|DRUG: Placebo|DRUG: Placebo
|
| Outcome Measures: |
Primary: F2-isoprostane (F2-iso), F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress., month 6 | Secondary: Interleukin-6 (IL-6), IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response., month 6
|
| Sponsor/Collaborators: |
Sponsor: Vanderbilt University | Collaborators: Fresenius Medical Care North America
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
385
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-04
|
| Completion Date: |
2010-09
|
| Results First Posted: |
2011-10-05
|
| Last Update Posted: |
2012-01-11
|
| Locations: |
Fresenius Medical Care North America, Nashville, Tennessee, 37215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00237718
|
