Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070993
Status:
COMPLETED
Last Update Posted:
2006-08-04
First Post:
2003-10-09
Brief Title:
Creatine for the Treatment of Amyotrophic Lateral Sclerosis
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Gehrigs Disease This study will test whether taking creatine can improve the symptoms of ALS
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None