Effects of N-Acetylcysteine on Muscle Fatigue in Hemodialysis (NAC)

Effects of N-Acetylcysteine on Muscle Fatigue in Hemodialysis (NAC)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), November 2008
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00440869

Purpose
The purposes of the study are to determine whether oxidative stress causes the muscle of dialysis patients to tire more quickly than muscle of people without kidney disease and to determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle endurance.

Condition Intervention Phase
End-Stage Renal Disease
Dialysis
Hemodialysis
Dietary Supplement: N-acetylcysteine
Dietary Supplement: placebo
Phase I

MedlinePlus related topics: Dialysis Dietary Supplements Kidney Failure Stress
Drug Information available for: Acetylcysteine
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:Effects of N-Acetylcysteine on Muscle Fatigue in ESRD

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
change in quadriceps muscle endurance during intermittent submaximal contractions [ Time Frame: 6 days ] [ Designated as safety issue: No ]

change in exercise-induced markers of oxidative stress [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Estimated Enrollment:30
Study Start Date:March 2007
Estimated Study Completion Date:June 2009
Estimated Primary Completion Date:June 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
N-acetylcysteine: Experimental
Active Dietary Supplement: N-acetylcysteine
600 mg po bid
placebo: Placebo Comparator
placebo Dietary Supplement: placebo
bid oral dosing

Detailed Description:
Muscle dysfunction is a major problem for patients with end-stage renal disease (ESRD). Specifically, these patients experience approximately three-fold greater muscle fatigue of the lower extremities during intermittent submaximal contractions than healthy control subjects. Thus, a treatment that could ameliorate muscle fatigue in this population has the potential to increase endurance during activities of daily living and improve quality of life. Dialysis patients have been shown to have high levels of various markers of oxidative stress, and oxidative stress has been associated with excessive muscle fatigue in other patient populations, but this link has not been established in the ESRD population.

Comparisons: The amount of muscle fatigue during intermittent submaximal quadriceps exercise between dialysis patients and controls will be compared. In addition, the degree of exercise-induced increase in markers of oxidative stress in muscle and in plasma will be compared between dialysis patients and controls and between dialysis patients who have received N-acetylcysteine for 6 days and those who have received placebo capsules.

Eligibility
Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Yes
Criteria
Inclusion Criteria:

age greater than 18 years
undergoing hemodialysis for 3 months or more or healthy control without kidney disease
Exclusion Criteria:

inability to give informed consent
diagnosis of diabetes mellitus
musculoskeletal contraindication to exercise
infection requiring intravenous antibiotics within 2 months
hospitalization within 2 months
ingestion of antioxidant supplements within one month
requirement for systemic anticoagulation
estimated GFR <60 ml/min/1.73 m2 for healthy controls
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440869

Contacts
Contact: Julie Doyle, MS 415-221-4810 ext 2596 julie.doyle2@va.gov

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Julie Doyle 415-221-4810

Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kirsten L Johansen, MD University of California, San Francisco, San Francisco VA Medical Center

Responsible Party:NCIRE, University of California, San Francisco ( Kirsten Johansen, MD )
Study ID Numbers:R21-DK077350-01, DK-077350-01
First Received:February 26, 2007
Last Updated:November 3, 2008
ClinicalTrials.gov Identifier:NCT00440869 [history]
Health Authority:United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
N-acetylcysteine
oxidative stress
muscle fatigue
end-stage renal disease
hemodialysis

Study placed in the following topic categories:
Renal Insufficiency
Fatigue
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Acetylcysteine
Stress
Kidney Diseases
N-monoacetylcystine
Kidney Failure

Additional relevant MeSH terms:
Anti-Infective Agents
Respiratory System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Expectorants
Physiological Effects of Drugs
Free Radical Scavengers
Protective Agents
Antiviral Agents
Pharmacologic Actions
Antidotes