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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 30, 2006
Last Update Posted: July 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
March 28, 2006
March 30, 2006
July 9, 2009
March 2006
July 2007   (Final data collection date for primary outcome measure)
A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker [ Time Frame: 4 months ]
The primary outcome will be a significant change in biomarkers of acute phase inflammation and oxidative stress in patients with Stage III and IV CKD.
Complete list of historical versions of study NCT00308971 on ClinicalTrials.gov Archive Site
  • A significant change in biomarkers of acute inflammation and oxidative stress from serum [ Time Frame: 4 months ]
  • A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography [ Time Frame: 4 months ]
The secondary outcome will improve endothelial vascular function in CKD.
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Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
  • Drug: Alpha, gamma, beta, and delta (mixed) tocopherols
    approximately 666 IU daily (1 pill) for 4 months
    Other Name: Vitamin E
  • 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
  • Active Comparator: 1
    • Drug: Alpha, gamma, beta, and delta (mixed) tocopherols
    • Drug: alpha lipoic acid
  • Placebo Comparator: 2
    • Drug: placebo
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2007
July 2007   (Final data collection date for primary outcome measure)

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 exclusion criteria)
  2. Active hepatitis C or B
  3. Active gout
  4. Other active inflammatory diseases.
  5. Active malignancy excluding basal or squamous cell carcinoma of the skin.
  6. Gastrointestinal dysfunction requiring parental nutrition.
  7. History of functional kidney transplant < 6 months prior to study entry.
  8. Anticipated live donor kidney transplant over study duration.
  9. Prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations.
  10. Patients taking Vitamin E supplements > 60 IU/day, vitamin C> 500mg/day over the past 30days.
  11. Patients taking anti-inflammatory medication except aspirin < 325mg/day over the past 30 days.
  12. Patient taking any prednisone therapy.
  13. More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days.
  14. On experimental drug protocols.
  15. Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin.
  16. Hypersensitivity to vitamin E or alpha lipoic acid.
  17. Pregnant women
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Alp Ikizler, MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Jonathan Himmelfarb, MD Maine Medical Center
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Vanderbilt University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP