Working... Menu

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

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. Identifier: NCT00308971
Recruitment Status : Completed
First Posted : March 30, 2006
Last Update Posted : July 9, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Alpha, gamma, beta, and delta (mixed) tocopherols Drug: alpha lipoic acid Drug: placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
Study Start Date : March 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Arm Intervention/treatment
Active Comparator: 1 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

Placebo Comparator: 2 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

Primary Outcome Measures :
  1. A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. A significant change in biomarkers of acute inflammation and oxidative stress from serum [ Time Frame: 4 months ]
  2. A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography [ Time Frame: 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308971

Layout table for location information
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Layout table for investigator information
Principal Investigator: Jonathan Himmelfarb, MD Maine Medical Center
Principal Investigator: Alp Ikizler, MD Vanderbilt University

Layout table for additonal information
Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center Identifier: NCT00308971     History of Changes
Other Study ID Numbers: 051000
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin E
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances