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Completed

NCT Number: NCT00308971

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maine Medical Center, Portland, Maine, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Stage III-IV chronic kidney disease measured by MDRD formula.
  • age > 18 or < 75 years.
  • Life expectancy greater than one year.
  • Ability to understand and provide informed consent for participation in the study

Exclusion criteria

  • AIDS (HIV seropositivity is not an exclusion criteria)
  • Active hepatitis C or B
  • Active gout
  • Other active inflammatory diseases.
  • Active malignancy excluding basal or squamous cell carcinoma of the skin.
  • Gastrointestinal dysfunction requiring parental nutrition.
  • History of functional kidney transplant < 6 months prior to study entry.
  • Anticipated live donor kidney transplant over study duration.
  • Prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations.
  • Patients taking Vitamin E supplements > 60 IU/day, vitamin C> 500mg/day over the past 30days.
  • Patients taking anti-inflammatory medication except aspirin < 325mg/day over the past 30 days.
  • Patient taking any prednisone therapy.
  • More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days.
  • On experimental drug protocols.
  • Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin.
  • Hypersensitivity to vitamin E or alpha lipoic acid.
  • Pregnant women

Treatment and study plan

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

Drug

approximately 666 IU daily (1 pill) for 4 months

Other names: Vitamin E

Alpha lipoic acid

Drug

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

Placebo

Drug

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

Primary outcomes

  1. A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker

    Time frame: 4 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 30, 2006
Registry last updated
Jul 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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