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

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00308971
First received: March 28, 2006
Last updated: July 8, 2009
Last verified: July 2009

March 28, 2006
July 8, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography [ Time Frame: 4 months ] [ Designated as safety issue: No ]
The secondary outcome will improve endothelial vascular function in CKD.
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Interventions:
    • Drug: Alpha, gamma, beta, and delta (mixed) tocopherols
    • Drug: alpha lipoic acid
  • Placebo Comparator: 2
    Interventions:
    • 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.
 
Completed
62
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00308971
051000
No
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