A Phase 1 interventional study of N-acetylcysteine and placebo in End-Stage Renal Disease, Dialysis and Hemodialysis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-03.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 1, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
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Exclusion Criteria:
Active
Dietary Supplement: N-acetylcysteine
placebo
Dietary Supplement: placebo
600 mg po bid
bid oral dosing
change in quadriceps muscle endurance during intermittent submaximal contractions
Time frame: 6 days
change in exercise-induced markers of oxidative stress
Time frame: 8 days
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)