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

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Alpha, gamma, beta, and delta (mixed) tocopherols; Drug: placebo; Drug: alpha lipoic acid

• Registration Number: NCT00308971
• Lead Sponsor: Vanderbilt University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-28
• Study First Submitted QC: 2006-03-28
• Study First Posted: 2006-03-30
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-08
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Alpha, gamma, beta, and delta (mixed) tocopherols	-
1	alpha lipoic acid	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker	4 months

Secondary Outcome Measures

Name	Time	Method
A significant change in biomarkers of acute inflammation and oxidative stress from serum	4 months
A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography	4 months

Trial Locations

Locations (2)

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States