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Completed

NCT Number: NCT00440869

Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Dietary Supplement

600 mg po bid

Placebo

Dietary Supplement

bid oral dosing

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Official study title

Effects of N-acetylcysteine on Muscle Fatigue in ESRD

Acronym: NAC

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2007
Registry last updated
Mar 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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