NCT00308971

Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on hemodialysis) populations, and several lines of evidence point to their contribution in the development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in these two populations. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress in patients with Stage III and IV CKD.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Alpha, gamma, beta, and delta (mixed) tocopherols	approximately 666 IU daily (1 pill) for 4 months
DRUG	alpha lipoic acid	600 mg daily (2 pills 300 mg each) for 4 months
DRUG	placebo	placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months
DRUG	placebo	placebo for alpha lipoic acid; 2 pills daily for 4 months

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-03-30
• Last updated: 2009-07-09

Locations

2 sites across 1 country: United States