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NCT Number: NCT01596803

Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)

On the basis of published data and the investigators' results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, the investigators propose a study to test whether or not an antioxidant supplementation has a therapeutic interest for patients with FSHD. Their results have important implications for the successful implementation of rational antioxidant therapy in FSHD in which cell loss could be linked to oxidative stress.

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Key information

Conditions

Facioscapulohumeral Muscular Dystrophy Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Motor Activity Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Facioscapulohumeral Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital- Saint Eloi Hospital

Montpellier, Languedoc-Roussillon, 34294, France

About this study

This study will compare the effect of the therapeutic interest of an antioxidant supplementation on the functional deficits and the molecular muscle abnormalities into two groups of patients affected by FSHD, one treated with the antioxidant supplementation during 17 weeks. The antioxidant by capsule consisted of:Vitamin E (400 mg /day), Selenium (200 µg/day in the form of selenomethionine), Vitamin C (500 mg/day), Zinc (25 mg/day in the form of gluconate). The second one treated with a placebo during 17 weeks. Patients will be assigned to intervention groups by chance, and neither physician, nor patient, will know which product is administrated (study in "double blind").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • FSHD patients will be recruited on the basis of:
  • The number of repeat units (4 to 9)
  • FSHD patients with a positive family history for FSHD
  • Not confined to a wheelchair
  • No smokers
  • No associated co-morbidity (cardiac or pulmonary disease, diabetes etc.)
  • No Medications or nutritional supplementation (vitamins and/or antioxidants) at the time of the study
  • No HIV positive

Exclusion criteria

  • No consent form

Treatment and study plan

Taking of blood

Procedure

Taking venous blood samples to analyse oxidant stress

needle biopsy of the vastus lateralis muscle

Dietary Supplement

T0 needle biopsy of the vastus lateralis muscle (analysis of oxidative stress and inflammatory markers)During 17 weeks supplementation by Vit E, C , Zn Se After 17 weeks: veinous blood samples and needle biopsy

Vit C Vit E Zn Se

Dietary Supplement

T0 venous blood samples and needle biopsy of the vastus lateralis muscle During 17 weeks vit E 400mg/d, Se 200µg/d, Vit C 500mg/day, Zn 25 mg/d After the supplementation of 17 weeks:venous blood samples and needle biopsy of the vastus lateralis muscle

Other names: FSHD, Antioxidant

Placebo Vit E Placebo Vit C Zn Se

Dietary Supplement

venous blood samples and needle biopsy

Primary outcomes

  1. Improvement of muscle effort tolerance after antioxidant supplementation

    Time frame: duration study 3 years

    17-weeks evaluation of an antioxidant supplementation in order to modulate or delay oxidative insult that could be useful to maintain FSHD muscle function. At T0, each patient will perform functionnal evaluation (Exercise Tolerance (2 minutes walking test), and/or Maximal Volontary Contraction and/or Endurance of quadriceps muscles).

Secondary outcomes

  1. Changes in inflammatory and oxidative stress parameters after antioxidant supplementation

    Time frame: duration study 3 years

    T0 evaluations spirometry, electrocardiogram, holter,Magnetic Resonance imaging of the both thighs,estimation muscle oxygen consumption during acute exercise . T7 venous blood samples (oxidative stress inflammatory markers)needle biopsy of the vastus lateralis muscle (oxidative stress inflammatory markers). analysis oxidative stress on muscle biochemical analyses.T7 patient receives placebo or antioxidant supplementation corresponding randomly-assigned trial. After 17 weeks supplementation the subjects will obtain venous blood samples and needle biopsy.

  2. Changes in muscular function after antioxidant supplementation

    Time frame: duration study 3 years

    T0 evaluations spirometry, electrocardiogram, holter Magnetic Resonance imaging of the both thighs,estimation muscle oxygen consumption . T7 venous blood samples (oxidative stress inflammatory markers)needle biopsy of the vastus lateralis muscle (oxidative stress inflammatory markers). This one-week lap's time is needed to avoid potential confounding effects of exercise-induced oxidative stress on muscle biochemical analyses.T7 patient receives placebo or antioxidant supplementation corresponding randomly-assigned trial. After 17 weeks supplementation venous blood samples and needle biopsy.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Association Amis FSH France
  • FSH Dutch Fondation The Netherland
  • Hospital Clinical Research Project 2010

Registry information

Official study title

Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)

Acronym: FSHD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 11, 2012
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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