Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy (MDB-GLN)
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| ClinicalTrials.gov Identifier: NCT00296621 |
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Recruitment Status :
Completed
First Posted : February 27, 2006
Last Update Posted : December 21, 2007
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Muscular Dystrophy, Duchenne | Drug: L-Glutamine Drug: placebo | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy Study of Oral Glutamine Supplementation in Duchenne Muscular Dystrophy |
| Study Start Date : | February 2006 |
| Estimated Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | November 2007 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: L-Glutamine
L-Glutamine |
| Placebo Comparator: 2 |
Drug: placebo
placebo |
- walking speed at 0,2,4,5,7,9 months [ Time Frame: at 0,2,4,5,7,9 months ]
- 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 ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296621
| France | |
| Centre d'Investigation Clinique, Hôpital Cardiologique, CHR&U de Lille | |
| Lille, France, 59037 | |
| Service d'Hépato Gastro Entérologie, Hôpital Jeanne de Flandre, CHR&U de Lille | |
| Lille, France, 59037 | |
| Service de Neuropédiatrie, Hôpital Roger Salengro, CHR&U de Lille | |
| Lille, France, 59037 | |
| Centre d'Investigation Clinique (CIC9202), Hôpital Robert Debré, Assistance Publique-Hôpitaux de Paris | |
| Paris, France, 75935 | |
| Pédiatrie Multidisciplinaire et Nutrition de l'Enfant, Centre Hospitalier Universitaire de Poitiers | |
| Poitiers, France, 86000 | |
| Principal Investigator: | Régis Hankard, MD, PhD | Centre Hospitalier Universitaire (CHU) de Poitiers |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Régis Hankard, MD PhD, CHU de Poitiers |
| ClinicalTrials.gov Identifier: | NCT00296621 |
| Other Study ID Numbers: |
P030420 AOM 03 121 |
| First Posted: | February 27, 2006 Key Record Dates |
| Last Update Posted: | December 21, 2007 |
| Last Verified: | December 2007 |
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glutamine nutrition children pediatrics randomized controlled clinical trial |
therapy supplement oral administration handicap |
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Muscular Dystrophies Muscular Dystrophy, Duchenne Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn Genetic Diseases, X-Linked |