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

February 26, 2007
March 2, 2010
March 2007
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • change in quadriceps muscle endurance during intermittent submaximal contractions
  • change in exercise-induced markers of oxidative stress
Complete list of historical versions of study NCT00440869 on ClinicalTrials.gov Archive Site
Not Provided
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Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis
Effects of N-acetylcysteine on Muscle Fatigue in ESRD

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • End-Stage Renal Disease
  • Dialysis
  • Hemodialysis
  • Dietary Supplement: N-acetylcysteine
    600 mg po bid
  • Dietary Supplement: placebo
    bid oral dosing
  • Experimental: N-acetylcysteine
    Active
    Intervention: Dietary Supplement: N-acetylcysteine
  • Placebo Comparator: placebo
    placebo
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00440869
R21-DK077350 (completed), DK-077350-01
No
Kirsten Johansen, MD, NCIRE, University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Kirsten L Johansen, MD University of California, San Francisco, San Francisco VA Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP