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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00440869
First received: February 26, 2007
Last updated: March 2, 2010
Last verified: March 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of N-acetylcysteine on Muscle Fatigue in ESRD

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-acetylcysteine
Active
 Dietary Supplement: N-acetylcysteine
600 mg po bid
Placebo Comparator: placebo
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

Locations
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)
Investigators
Principal Investigator: Kirsten L Johansen, MD University of California, San Francisco, San Francisco VA Medical Center
  More Information

No publications provided

Responsible Party: Kirsten Johansen, MD, NCIRE, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00440869     History of Changes
Other Study ID Numbers: R21-DK077350 (completed), DK-077350-01
Study First Received: February 26, 2007
Last Updated: March 2, 2010
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

Additional relevant MeSH terms:
Fatigue
Kidney Diseases
Kidney Failure, Chronic
Signs and Symptoms
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 22, 2013