Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016653
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
2001-05-21
Brief Title:
Creatine and Glutamine in Steroid-Naive Duchenne Muscular Dystrophy
Sponsor:
Cooperative International Neuromuscular Research Group
Organization:
Cooperative International Neuromuscular Research Group
Study Overview
Official Title:
A Multicenter Randomized Placebo-controlled Double-blind Study to Assess Efficacy and Safety of Glutamine and Creatine Monohydrate in Duchenne Muscular Dystrophy
Status:
COMPLETED
Status Verified Date:
2011-10
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:
This study will help to determine the effectiveness of glutamine and creatine as a possible therapy for DMD Boys with DMD who are enrolled in this trial will be randomly chosen to receive creatine monohydrate or glutamine or an inactive placebo orally for six months Once a month during the six-month treatment period the study participants will have their muscle strength evaluated using manual and computerized testing methods This study will be conducted at several CINRG Centers throughout the US Belgium Israel and Puerto Rico This study is supported by the Muscular Dystrophy Association
Detailed Description:
PURPOSE OF THE STUDY The purpose of this study is to see if children with Duchenne muscular dystrophy DMD who are given glutamine a nutritional supplement or creatine monohydrate a nutritional supplement have changes in strength compared to children who are given no medicinal treatment Children who are chosen to be in this research study will be diagnosed with DMD be between the ages of 5 and 10 years old and will not have participated in any other DMD clinical trials within the last year and will not have been on medications that disqualify them from participation in this trial All children in this clinical trial are entered at the discretion of the doctors in charge of the study During the first and second visits children who fulfill the criteria for participation in the clinical trial will be determined We expect 50 subjects to participate at CINRG centers worldwide
PROCEDURES
Children will be randomized a procedure like flipping a coin into one of three groups treated with glutamine treated with creatine monohydrate or untreated placebo a sugar pill with no medication Neither parents children nor the doctors treating the children will know the group each child has been assigned to Because of the study design there is a possibility that children will receive no treatment placebo group during the clinical trial During the trial children must take one supplement mixed with water in the morning and supplements mixed with water each night
Nine 9 clinic visits are required to complete this clinical trial During visits to the clinic each child will be evaluated by members of the research team to determine the childs strength Strength will be measured in different ways manual testing quantitative testing and the usual measures used during visits to the neurologist child will be asked to rise from the floor walk across room etc Manual testing is the way strength is usually measured by your childs doctor The quantitative muscle strength test QMT is a mechanical way to measure strength the child sitslays on an examining table and is asked to pullpush a strap This test will determine the strength of different muscle groups in kilograms of force An electrocardiogram ECG a heart test will be performed during screening visit 2 and month 6 and blood a small amount equal to about 2 to 3 tablespoons will be drawn on screening visit 2 and months 1 3 and 6 Urine tests will be done at screening visit 2 nd months 1 3 and 6 to monitor kidney function
PROCEDURES
Children will be randomized a procedure like flipping a coin into one of three groups treated with glutamine treated with creatine monohydrate or untreated placebo a sugar pill with no medication Neither parents children nor the doctors treating the children will know the group each child has been assigned to Because of the study design there is a possibility that children will receive no treatment placebo group during the clinical trial During the trial children must take one supplement mixed with water in the morning and supplements mixed with water each night
Nine 9 clinic visits are required to complete this clinical trial During visits to the clinic each child will be evaluated by members of the research team to determine the childs strength Strength will be measured in different ways manual testing quantitative testing and the usual measures used during visits to the neurologist child will be asked to rise from the floor walk across room etc Manual testing is the way strength is usually measured by your childs doctor The quantitative muscle strength test QMT is a mechanical way to measure strength the child sitslays on an examining table and is asked to pullpush a strap This test will determine the strength of different muscle groups in kilograms of force An electrocardiogram ECG a heart test will be performed during screening visit 2 and month 6 and blood a small amount equal to about 2 to 3 tablespoons will be drawn on screening visit 2 and months 1 3 and 6 Urine tests will be done at screening visit 2 nd months 1 3 and 6 to monitor kidney 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