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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00296621 |
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).
Condition | Intervention | Phase |
---|---|---|
Muscular Dystrophy, Duchenne |
Drug: L-Glutamine Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Efficacy Study of Oral Glutamine Supplementation in Duchenne Muscular Dystrophy |
Enrollment: | 30 |
Study Start Date: | February 2006 |
Study Completion Date: | November 2007 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: L-Glutamine
L-Glutamine
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2: Placebo Comparator |
Drug: placebo
placebo
|
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).
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Pédiatrie Multidisciplinaire et Nutrition de l'Enfant, Centre Hospitalier Universitaire de Poitiers | |
Poitiers, France, 86000 | |
Service de Neuropédiatrie, Hôpital Roger Salengro, CHR&U de Lille | |
Lille, France, 59037 | |
Service d'Hépato Gastro Entérologie, Hôpital Jeanne de Flandre, CHR&U de Lille | |
Lille, France, 59037 | |
Centre d'Investigation Clinique, Hôpital Cardiologique, CHR&U de Lille | |
Lille, France, 59037 | |
Centre d'Investigation Clinique (CIC9202), Hôpital Robert Debré, Assistance Publique-Hôpitaux de Paris | |
Paris, France, 75935 |
Principal Investigator: | Régis Hankard, MD, PhD | Centre Hospitalier Universitaire (CHU) de Poitiers |
Responsible Party: | CHU de Poitiers ( Régis Hankard, MD PhD ) |
Study ID Numbers: | P030420, AOM 03 121 |
Study First Received: | February 23, 2006 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00296621 |
Health Authority: | France: Ministry of Health |
glutamine nutrition children pediatrics randomized controlled clinical trial |
therapy supplement oral administration handicap |
Muscular dystrophy, Duchenne and Becker type Muscular Dystrophies Muscular Diseases Becker's muscular dystrophy Muscular Disorders, Atrophic Musculoskeletal Diseases Neuromuscular Diseases |
Genetic Diseases, Inborn Muscular Dystrophy, Duchenne Genetic Diseases, X-Linked Duchenne muscular dystrophy Atrophy Muscular dystrophy |
Nervous System Diseases |