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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00308971

Enrollment

Registered

2006-03-30

Start date

2006-03-31

Completion date

2007-07-31

Last updated

2009-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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.

Interventions

DRUGAlpha, gamma, beta, and delta (mixed) tocopherols

approximately 666 IU daily (1 pill) for 4 months

DRUGalpha lipoic acid

600 mg daily (2 pills 300 mg each) for 4 months

DRUGplacebo

placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Patients with Stage III-IV chronic kidney disease measured by MDRD formula. 2. age \> 18 or \< 75 years. 3. Life expectancy greater than one year. 4. Ability to understand and provide informed consent for participation in the study

Exclusion criteria

1. AIDS (HIV seropositivity is not an

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026