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

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: NCT00440869
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : March 3, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
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 or disease Intervention/treatment Phase
End-Stage Renal Disease Dialysis Hemodialysis Dietary Supplement: N-acetylcysteine Dietary Supplement: placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of N-acetylcysteine on Muscle Fatigue in ESRD
Study Start Date : March 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Arm Intervention/treatment
Experimental: N-acetylcysteine
Dietary Supplement: N-acetylcysteine
600 mg po bid
Placebo Comparator: placebo
Dietary Supplement: placebo
bid oral dosing

Primary Outcome Measures :
  1. change in quadriceps muscle endurance during intermittent submaximal contractions [ Time Frame: 6 days ]
  2. change in exercise-induced markers of oxidative stress [ Time Frame: 8 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT00440869

United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kirsten L Johansen, MD University of California, San Francisco, San Francisco VA Medical Center

Responsible Party: Kirsten Johansen, MD, NCIRE, University of California, San Francisco Identifier: NCT00440869     History of Changes
Other Study ID Numbers: R21-DK077350 (completed)
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Signs and Symptoms
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs