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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Alpha, gamma, beta, and delta (mixed) tocopherols

Intervention Type DRUG

approximately 666 IU daily (1 pill) for 4 months

alpha lipoic acid

Intervention Type DRUG

600 mg daily (2 pills 300 mg each) for 4 months

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months

placebo

Intervention Type DRUG

placebo for alpha lipoic acid; 2 pills daily for 4 months

Interventions

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Alpha, gamma, beta, and delta (mixed) tocopherols

approximately 666 IU daily (1 pill) for 4 months

Intervention Type DRUG

alpha lipoic acid

600 mg daily (2 pills 300 mg each) for 4 months

Intervention Type DRUG

placebo

placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 4 months

Intervention Type DRUG

placebo

placebo for alpha lipoic acid; 2 pills daily for 4 months

Intervention Type DRUG

Other Intervention Names

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Vitamin E

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No