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

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ClinicalTrials.gov Identifier: NCT01596803
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
Hospital Clinical Research Project 2010
Association Amis FSH France
FSH Dutch Fondation The Netherland
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
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 Not Applicable

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").
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)
Actual Study Start Date : May 1, 2010
Actual Primary Completion Date : February 20, 2012
Actual Study Completion Date : June 1, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT01596803


Locations
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France
Montpellier University Hospital- Saint Eloi Hospital
Montpellier, Languedoc-Roussillon, France, 34294
Sponsors and Collaborators
University Hospital, Montpellier
Hospital Clinical Research Project 2010
Association Amis FSH France
FSH Dutch Fondation The Netherland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01596803    
Other Study ID Numbers: 8426
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by University Hospital, Montpellier:
FSHD
Antioxidants
Oxidative stress
Muscle function
 Quality of life
Activity
(FSHD;4q35)
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Ascorbic Acid
 Vitamin E
alpha-Tocopherol
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients