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

NCT00308971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2009-07-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Jonathan Himmelfarb, MD · MaineHealth

  • Alp Ikizler, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00308971 on ClinicalTrials.gov