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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital Clinical Research Project 2010
Association Amis FSH France
FSH Dutch Fondation The Netherland
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01596803
First received: April 5, 2012
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Facioscapulohumeral Muscular Dystrophy
Procedure: Taking of blood
Dietary Supplement: needle biopsy of the vastus lateralis muscle
Dietary Supplement: Vit C Vit E Zn Se
Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Improvement of muscle effort tolerance after antioxidant supplementation [ Time Frame: duration study 3 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Changes in inflammatory and oxidative stress parameters after antioxidant supplementation [ Time Frame: duration study 3 years ] [ Designated as safety issue: No ]
    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.

  • Changes in muscular function after antioxidant supplementation [ Time Frame: duration study 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 54
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamins minerals
VitE 400/d, vitC 500mg/d, Se 200µg/d (selenomethionine), Zn 25 mg/d gluconate Venous blood samples( analysis oxidative stress inflammatory markers) Needle biopsy of the vastus lateralis muscle (analysis oxidative stress inflammatory markers)
Procedure: Taking of blood
Taking venous blood samples to analyse oxidant stress
Dietary Supplement: needle biopsy of the vastus lateralis muscle
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
Dietary Supplement: Vit C Vit E Zn Se
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 Comparator: Placebo
Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle
Procedure: Taking of blood
Taking venous blood samples to analyse oxidant stress
Dietary Supplement: needle biopsy of the vastus lateralis muscle
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
Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se
venous blood samples and needle biopsy

Detailed Description:

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").

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596803

Contacts
Contact: Jacques JM Mercier, MD, PhD 33(4)67335908 jacques.mercier@univ-montp1.fr

Locations
France
Montpellier University Hospital- Saint Eloi Hospital Recruiting
Montpellier, Languedoc-Roussillon, France, 34294
Contact: Jacques JM Mercier, MD, PhD    33(4)67335908    jacques.mercier@univ-montp1.fr   
Principal Investigator: Jacques mercier, MD PhD         
Sponsors and Collaborators
University Hospital, Montpellier
Hospital Clinical Research Project 2010
Association Amis FSH France
FSH Dutch Fondation The Netherland
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01596803     History of Changes
Other Study ID Numbers: UF 8426
Study First Received: April 5, 2012
Last Updated: May 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
FSHD
Antioxidants
Oxidative stress
Muscle function
Quality of life
Activity
(FSHD;4q35)

Additional relevant MeSH terms:
Muscular Dystrophy, Facioscapulohumeral
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Antioxidants
Vitamin E
Alpha-Tocopherol
Tocopherols
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014