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Completed

NCT Number: NCT00237718

Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fresenius Medical Care North America

Nashville, Tennessee, 37215, United States

About this study

Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. 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 while improving the erythropoietic response in hemodialysis patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with end-stage renal disease receiving thrice weekly hemodialysis
  • Age > 18 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 malignancy excluding basal cell carcinoma of the skin
  • Gastrointestinal dysfunction requiring parenteral nutrition
  • History of functional kidney transplant < 6 months prior to study entry
  • Anticipated live donor kidney transplant over study duration
  • History of poor adherence to hemodialysis or medical regimen
  • Prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations
  • Patients taking vitamin E supplements > 60 IU/day, vitamin C > 500 mg/day over the past 30 days
  • Patients taking anti-inflammatory medication except aspirin < 325 mg/day over the past 30 days
  • Patients using a temporary catheter for dialysis access
  • More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days

Treatment and study plan

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

Drug

approximately 666 IU daily (1 pill) for 6 months

Other names: Vitamin E

Alpha lipoic acid

Drug

600 mg daily (2 pills 300 mg each) for 6 months

Placebo

Drug

placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months

Primary outcomes

  1. F2-isoprostane (F2-iso)

    Time frame: month 6

    F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.

Secondary outcomes

  1. Interleukin-6 (IL-6)

    Time frame: month 6

    IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Fresenius Medical Care North America

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 12, 2005
Registry last updated
Jan 11, 2012

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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