NCT00440869

Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis

Effects of N-acetylcysteine on Muscle Fatigue in ESRD

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• End-Stage Renal Disease
• Dialysis
• Hemodialysis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	N-acetylcysteine	600 mg po bid
DIETARY_SUPPLEMENT	placebo	bid oral dosing

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-02-27
• Last updated: 2010-03-03

Locations

1 site across 1 country: United States