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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00070993 |
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.
Condition | Intervention | Phase |
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Amyotrophic Lateral Sclerosis |
Drug: creatine monohydrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis |
Estimated Enrollment: | 110 |
Study Start Date: | December 2002 |
Estimated Study Completion Date: | May 2006 |
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.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, California | |
California Pacific Medical Center | |
San Francisco, California, United States, 94115 | |
United States, Illinois | |
Rush-Presbyterian St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, New Mexico | |
University of New Mexico - Medical Center | |
Albuquerque, New Mexico, United States, 87131 | |
United States, Texas | |
University of Texas Health and Science Center | |
San Antonio, Texas, United States, 78284 | |
United States, Virginia | |
University of Virginia Health System | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Jeffrey Rosenfeld, MD | Carolinas Medical Center |
Study ID Numbers: | R01 AT000967-01 |
Study First Received: | October 9, 2003 |
Last Updated: | August 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00070993 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ALS Creatine |
Lou Gehrig's Disease Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Central Nervous System Diseases |
Sclerosis Neurodegenerative Diseases Degenerative Motor System Disease Motor Neuron Disease |
Pathologic Processes Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Nervous System Diseases |
Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Motor Neuron Disease |