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Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237718
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : October 5, 2011
Last Update Posted : January 11, 2012
Fresenius Medical Care North America
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Drug: Alpha, gamma, beta, and delta (mixed) tocopherols Drug: Alpha lipoic acid Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
Study Start Date : April 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Active Comparator: ALA and Vitamin E
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
Drug: Alpha, gamma, beta, and delta (mixed) tocopherols
approximately 666 IU daily (1 pill) for 6 months
Other Name: Vitamin E

Drug: Alpha lipoic acid
600 mg daily (2 pills 300 mg each) for 6 months

Placebo Comparator: Placebo
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
Drug: Placebo
placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months

Drug: Placebo
placebo for alpha lipoic acid; 2 pills daily for 6 months

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237718

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United States, Tennessee
Fresenius Medical Care North America
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Vanderbilt University
Fresenius Medical Care North America
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Principal Investigator: Jonathan Himmelfarb, MD MaineHealth
Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center
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Responsible Party: Alp Ikizler, Professor, Vanderbilt University Identifier: NCT00237718    
Other Study ID Numbers: 050377
First Posted: October 12, 2005    Key Record Dates
Results First Posted: October 5, 2011
Last Update Posted: January 11, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin E
Thioctic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamin B Complex