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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308971
• Other study ID #: 051000
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2006
• Last updated: July 8, 2009
• Start date: March 2006
• Est. completion date: July 2007

Study information

• Verified date: July 2009
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Alpha, gamma, beta, and delta (mixed) tocopherols
approximately 666 IU daily (1 pill) for 4 months
• alpha lipoic acid
600 mg daily (2 pills 300 mg each) for 4 months
• placebo
placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months
• placebo
placebo for alpha lipoic acid; 2 pills daily for 4 months

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Maine Medical Center	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker		4 months	No
Secondary	A significant change in biomarkers of acute inflammation and oxidative stress from serum		4 months	No
Secondary	A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography		4 months	No