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Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Creatine is a naturally occurring chemical involved in the production of energy in muscle. Abnormalities in creatine have been linked to the progression of degenerative neuromuscular diseases such as amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). This study will test whether taking creatine can improve the symptoms of ALS.
Amyotrophic lateral sclerosis is a progressive neurodegenerative disorder selectively affecting motor neurons, resulting in progressive weakness. Currently there is no known cure and a specific cause has not been identified. Creatine is a nutritional supplement that improves mitochondrial function and has been shown to protect motor neurons in animal models of ALS. Preliminary research indicates that creatine may also improve strength in patients with ALS. This study will determine the effect of creatine treatment on short-term muscle strength and long-term muscle deterioration in patients with ALS. Participants in this study will be randomly assigned to receive either creatine or placebo. Participants will be enrolled in the study for 9 months. Quantitative muscle testing will be done weekly for the first 3 weeks; participants will then be followed monthly for the next 4 months and bimonthly for the remainder of the 9-month study. The study will also monitor purposeful exercise to determine if this enhances the benefit of creatine usage on muscle strength. Pulmonary function testing will accompany the muscle testing to determine if creatine strengthens respiratory muscles, thereby enhancing pulmonary function.
Age
21 - 80 years
Sex
ALL
Healthy Volunteers
No
California Pacific Medical Center
San Francisco, California, United States
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of New Mexico - Medical Center
Albuquerque, New Mexico, United States
University of Texas Health and Science Center
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Start Date
December 1, 2002
Completion Date
May 1, 2006
Last Updated
August 4, 2006
110
Estimated participants
creatine monohydrate
DRUG
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
NCT07322003
NCT05104710
NCT04715399
Data Source & Attribution
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