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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00440869 |
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 I |
| MedlinePlus related topics: | Dialysis Dietary Supplements Kidney Failure Stress |
| ChemIDplus related topics: | Acetylcysteine Kaopectate Attapulgite Bismuth subsalicylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effects of N-Acetylcysteine on Muscle Fatigue in ESRD |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
N-acetylcysteine: Experimental
Active
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Dietary Supplement: N-acetylcysteine
600 mg po bid
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placebo: Placebo Comparator
placebo
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Dietary Supplement: placebo
bid oral dosing
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Julie Doyle, MS | 415-221-4810 ext 2596 | julie.doyle2@va.gov |
| United States, California | |||||
| San Francisco VA Medical Center | Recruiting | ||||
| San Francisco, California, United States, 94121 | |||||
| Contact: Julie Doyle 415-221-4810 | |||||
| Principal Investigator: | Kirsten L Johansen, MD | University of California, San Francisco, San Francisco VA Medical Center |
More Information
| Responsible Party: | NCIRE, University of California, San Francisco ( Kirsten Johansen, MD ) |
| Study ID Numbers: | R21-DK077350-01, DK-077350-01 |
| First Received: | February 26, 2007 |
| Last Updated: | May 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00440869 |
| Health Authority: | United States: Federal Government |
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