CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 385 enrolled
Drug / intervention
Alpha, gamma, beta, and delta (mixed) tocopherols +3 moredrug
Likely dose
Mixed tocopherols approximately 666 IU daily (1 pill) and/or alpha lipoic acid 600 mg daily (2 pills 300 mg each) for 6 monthsAI-extracted
Key inclusion· 4
  • ✓End-stage renal disease patients on thrice-weekly hemodialysis
  • ✓Age >18 years
  • ✓Life expectancy greater than one year
  • ✓Ability to provide informed consent
Key exclusion· 9
  • ✕AIDS (HIV seropositivity alone is not exclusionary)
  • ✕Active malignancy excluding basal cell carcinoma of skin
  • ✕Gastrointestinal dysfunction requiring parenteral nutrition
  • ✕Functional kidney transplant within 6 months prior to study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00237718
NCT00237718Phase 2Completed
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Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Vanderbilt University·interventional·Posted Oct 12, 2005·Updated Jan 11, 2012

In Brief

A Phase 2 clinical trial evaluating Alpha, gamma, beta, and delta (mixed) tocopherols, Alpha lipoic acid, and 1 other intervention for End-stage Renal Disease. Completed, enrolled 385 participants across 1 site.

Detailed Summary

Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd-stage Renal Disease
CountriesUnited States
CollaboratorsFresenius Medical Care North America

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2005
Enrollment StartApr 1, 2006
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.7 years ago

Interventions

Alpha, gamma, beta, and delta (mixed) tocopherolsdrug

approximately 666 IU daily (1 pill) for 6 months

Alpha lipoic aciddrug

600 mg daily (2 pills 300 mg each) for 6 months

Placebodrug

placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months

Placebodrug

placebo for alpha lipoic acid; 2 pills daily for 6 months