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Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy (MDB-GLN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00296621
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : December 21, 2007
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 23, 2006
First Posted Date  ICMJE February 27, 2006
Last Update Posted Date December 21, 2007
Study Start Date  ICMJE February 2006
Estimated Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
walking speed at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2006)
walking speed at 0,2,4,5,7,9 months
Change History Complete list of historical versions of study NCT00296621 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • work (kcal) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
  • power (kcal/s) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
  • 2-minute walk test at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
  • body composition (bioelectrical impedance analysis) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
  • body composition (BIPHOTONIC absorptiometry) at 4,9 months [ Time Frame: at 4,9 months ]
  • muscle mass (24-h urinary creatinine excretion) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
  • indices of protein degradation (CPK and 3-methyl histidine excretion) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
  • biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, IgfI, Igf-BP3) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2006)
  • work (kcal) at 0,2,4,5,7,9 months
  • power (kcal/s) at 0,2,4,5,7,9 months
  • 2-minute walk test at 0,2,4,5,7,9 months
  • body composition (bioelectrical impedance analysis) at 0,2,4,5,7,9 months
  • body composition (BIPHOTONIC absorptiometry) at 4,9 months
  • muscle mass (24-h urinary creatinine excretion) at 0,2,4,5,7,9 months
  • indices of protein degradation (CPK and 3-methyl histidine excretion) at 0,2,4,5,7,9 months
  • biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, IgfI, Igf-BPI) at 0,2,4,5,7,9 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy
Official Title  ICMJE Efficacy Study of Oral Glutamine Supplementation in Duchenne Muscular Dystrophy
Brief Summary The purpose of this study is to determine whether long-term oral glutamine supplementation is effective in improving muscle mass and function in children with Duchenne muscular dystrophy (DMD).
Detailed Description

Glutamine inhibits whole body protein degradation in children with Duchenne Muscular Dystrophy (DMD). The effect is observed after 5 h oral glutamine administration and is also found when glutamine is given over a 10-day period. This multi-site national study aims to evaluate the functional benefit of long-term oral glutamine administration in 30 DMD children using a randomized double-blind placebo-controlled cross-over design. The study includes two 4-month periods: 1) a treatment period in which the subject receives oral glutamine (0.5 g/kg/d) and 2) a control period in which the subject receives a placebo. The order of treatment allocation is randomized. The two 4-month periods are separated by a 1 month wash-out period. The children are monitored every 2 months during period 1 (M0, M2, M4) and period 2 (M5, M7, M9) in the clinical investigation centres of Hospital Robert Debré in Paris and the CHR&U de Lille, as well as the clinical research centre of the CHU de Poitiers. Evidence of a functional benefit would involve evaluating the administration of glutamine over longer periods (as early as possible following diagnosis) among severely handicapped children and in other chronic pathologies associated with increased muscle protein catabolism. In DMD, such evidence would enable children to undergo gene therapy under improved physical condition.

Comparisons: Glutamine administration compared to placebo on the following outcome measures: walking speed on a standard course, work (kcal) and power (kcal/s) in relation to effort, body composition (bioelectrical impedance analysis and BIPHOTONIC absorptiometry), muscle mass (24-h urinary creatinine excretion), indices of protein degradation (CPK and 3-methyl histidine excretion) and biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, IgfI, Igf-BPI).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Muscular Dystrophy, Duchenne
Intervention  ICMJE
  • Drug: L-Glutamine
    L-Glutamine
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: L-Glutamine
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2006)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Estimated Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of Duchenne muscular dystrophy
  • Able to walk >170 m
  • Absence of hepatic insufficiency
  • Absence of renal insufficiency

Exclusion Criteria:

  • Dependent upon wheelchair
  • Body weight >60kg
  • Liver failure
  • Kidney failure
  • Surgery scheduled during the year following the first visit
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00296621
Other Study ID Numbers  ICMJE P030420
AOM 03 121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Régis Hankard, MD PhD, CHU de Poitiers
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Régis Hankard, MD, PhD Centre Hospitalier Universitaire (CHU) de Poitiers
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP