Creatine and Glutamine in Steroid-Naive Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2/Phase 3

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 U.S., 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 child?s
      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 child?s doctor. The quantitative muscle strength test (QMT) is a mechanical
      way to measure strength: the child sits/lays on an examining table and is asked to pull/push
      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.
    

Intervention name(s): Creatine Monohydrate; Glutamine
Intervention type(s): Drug; Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Duchenne; muscular; dystrophy; treatment