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Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

NCT00237718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2012-01-11

Study results available
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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.

Conditions

  • End-stage Renal Disease

Interventions

DRUG

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

approximately 666 IU daily (1 pill) for 6 months

DRUG

Alpha lipoic acid

600 mg daily (2 pills 300 mg each) 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

Sponsors & Collaborators

  • Fresenius Medical Care North America

    collaborator INDUSTRY

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Jonathan Himmelfarb, MD · MaineHealth

  • Alp Ikizler, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00237718 on ClinicalTrials.gov