Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy

NCT00296621 | Completed Phase 2

• 2 other identifiers: P030420AOM 03 121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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).

Conditions

Muscular Dystrophy, Duchenne

Keywords

glutamine; nutrition; children; pediatrics; randomized controlled clinical trial; therapy; supplement; oral administration; handicap

Outcome Measures

Primary Outcomes (1)

• walking speed at 0,2,4,5,7,9 months

  at 0,2,4,5,7,9 months

Secondary Outcomes (8)

• work (kcal) at 0,2,4,5,7,9 months

  at 0,2,4,5,7,9 months

• power (kcal/s) at 0,2,4,5,7,9 months

  at 0,2,4,5,7,9 months

• 2-minute walk test at 0,2,4,5,7,9 months

  at 0,2,4,5,7,9 months

• body composition (bioelectrical impedance analysis) at 0,2,4,5,7,9 months

  at 0,2,4,5,7,9 months

• body composition (BIPHOTONIC absorptiometry) at 4,9 months

  at 4,9 months

Study Arms (2)

1

EXPERIMENTAL

Drug: L-Glutamine

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

L-Glutamine DRUG

L-Glutamine

1

placebo DRUG

placebo

2

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dependent upon wheelchair
• Body weight \>60kg
• Liver failure
• Kidney failure
• Surgery scheduled during the year following the first visit

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (5)

Centre d'Investigation Clinique, Hôpital Cardiologique, CHR&U de Lille

Lille, 59037, France

Location

Service d'Hépato Gastro Entérologie, Hôpital Jeanne de Flandre, CHR&U de Lille

Lille, 59037, France

Location

Service de Neuropédiatrie, Hôpital Roger Salengro, CHR&U de Lille

Lille, 59037, France

Location

Centre d'Investigation Clinique (CIC9202), Hôpital Robert Debré, Assistance Publique-Hôpitaux de Paris

Paris, 75935, France

Location

Pédiatrie Multidisciplinaire et Nutrition de l'Enfant, Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

Related Publications (7)

• Mok E, Eleouet-Da Violante C, Daubrosse C, Gottrand F, Rigal O, Fontan JE, Cuisset JM, Guilhot J, Hankard R. Oral glutamine and amino acid supplementation inhibit whole-body protein degradation in children with Duchenne muscular dystrophy. Am J Clin Nutr. 2006 Apr;83(4):823-8. doi: 10.1093/ajcn/83.4.823.

  PMID: 16600934 BACKGROUND

• Hankard R, Mauras N, Hammond D, Haymond M, Darmaun D. Is glutamine a 'conditionally essential' amino acid in Duchenne muscular dystrophy? Clin Nutr. 1999 Dec;18(6):365-9. doi: 10.1016/s0261-5614(99)80017-x.

  PMID: 10634922 BACKGROUND

• Hankard RG, Hammond D, Haymond MW, Darmaun D. Oral glutamine slows down whole body protein breakdown in Duchenne muscular dystrophy. Pediatr Res. 1998 Feb;43(2):222-6. doi: 10.1203/00006450-199802000-00011.

  PMID: 9475288 BACKGROUND

• Hankard RG, Haymond MW, Darmaun D. Effect of glutamine on leucine metabolism in humans. Am J Physiol. 1996 Oct;271(4 Pt 1):E748-54. doi: 10.1152/ajpendo.1996.271.4.E748.

  PMID: 8897864 BACKGROUND

• Hankard RG, Darmaun D, Sager BK, D'Amore D, Parsons WR, Haymond M. Response of glutamine metabolism to exogenous glutamine in humans. Am J Physiol. 1995 Oct;269(4 Pt 1):E663-70. doi: 10.1152/ajpendo.1995.269.4.E663.

  PMID: 7485479 BACKGROUND

• Mok E, Beghin L, Gachon P, Daubrosse C, Fontan JE, Cuisset JM, Gottrand F, Hankard R. Estimating body composition in children with Duchenne muscular dystrophy: comparison of bioelectrical impedance analysis and skinfold-thickness measurement. Am J Clin Nutr. 2006 Jan;83(1):65-9. doi: 10.1093/ajcn/83.1.65.

  PMID: 16400051 BACKGROUND

• Mok E, Letellier G, Cuisset JM, Denjean A, Gottrand F, Alberti C, Hankard R. Lack of functional benefit with glutamine versus placebo in Duchenne muscular dystrophy: a randomized crossover trial. PLoS One. 2009;4(5):e5448. doi: 10.1371/journal.pone.0005448. Epub 2009 May 6.

  PMID: 19421321 DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Régis Hankard, MD, PhD

  Centre Hospitalier Universitaire (CHU) de Poitiers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: November 1, 2007
• Last Updated: December 21, 2007

Record last verified: 2007-12

Locations

FR (5)