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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00296621
First received: February 23, 2006
Last updated: December 20, 2007
Last verified: December 2007

February 23, 2006
December 20, 2007
February 2006
February 2008   (final data collection date for primary outcome measure)
walking speed at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ] [ Designated as safety issue: Yes ]
walking speed at 0,2,4,5,7,9 months
Complete list of historical versions of study NCT00296621 on ClinicalTrials.gov Archive Site
  • work (kcal) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ] [ Designated as safety issue: Yes ]
  • power (kcal/s) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ] [ Designated as safety issue: Yes ]
  • 2-minute walk test at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ] [ Designated as safety issue: Yes ]
  • body composition (bioelectrical impedance analysis) at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ] [ Designated as safety issue: Yes ]
  • body composition (BIPHOTONIC absorptiometry) at 4,9 months [ Time Frame: at 4,9 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy
Efficacy Study of Oral Glutamine Supplementation in Duchenne Muscular Dystrophy

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).

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Muscular Dystrophy, Duchenne
  • Drug: L-Glutamine
    L-Glutamine
    Other Name: L-Glutamine
  • Drug: placebo
    placebo
    Other Name: placebo
  • Experimental: 1
    Intervention: Drug: L-Glutamine
  • Placebo Comparator: 2
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2007
February 2008   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00296621
P030420, AOM 03 121
No
Régis Hankard, MD PhD, CHU de Poitiers
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Régis Hankard, MD, PhD Centre Hospitalier Universitaire (CHU) de Poitiers
Assistance Publique - Hôpitaux de Paris
December 2007

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