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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
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: March 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308971

Locations
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
Investigators
Principal Investigator: Jonathan Himmelfarb, MD Maine Medical Center
Principal Investigator: Alp Ikizler, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00308971     History of Changes
Other Study ID Numbers: 051000
Study First Received: March 28, 2006
Last Updated: July 8, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Thioctic Acid
Vitamin E
Tocopherols
Tocotrienols
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013