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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 : Unknown
Verified May 2012 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : May 11, 2012
Last Update Posted : May 11, 2012
Sponsor:
Collaborators:
Hospital Clinical Research Project 2010
Association Amis FSH France
FSH Dutch Fondation The Netherland
Information provided by (Responsible Party):
University Hospital, Montpellier

April 5, 2012
May 11, 2012
May 11, 2012
June 2010
April 2013   (Final data collection date for primary outcome measure)
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).
Same as current
No Changes Posted
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by 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.
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").
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Facioscapulohumeral Muscular Dystrophy
  • 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
  • Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se
    venous blood samples and needle biopsy
  • 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)
    Interventions:
    • Procedure: Taking of blood
    • Dietary Supplement: needle biopsy of the vastus lateralis muscle
    • Dietary Supplement: Vit C Vit E Zn Se
  • Placebo Comparator: Placebo
    Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle
    Interventions:
    • Procedure: Taking of blood
    • Dietary Supplement: needle biopsy of the vastus lateralis muscle
    • Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se
Passerieux E, Hayot M, Jaussent A, Carnac G, Gouzi F, Pillard F, Picot MC, Böcker K, Hugon G, Pincemail J, Defraigne JO, Verrips T, Mercier J, Laoudj-Chenivesse D. Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial. Free Radic Biol Med. 2015 Apr;81:158-69. doi: 10.1016/j.freeradbiomed.2014.09.014. Epub 2014 Sep 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
54
Same as current
December 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01596803
UF 8426
Yes
Not Provided
Not Provided
University Hospital, Montpellier
University Hospital, Montpellier
  • Hospital Clinical Research Project 2010
  • Association Amis FSH France
  • FSH Dutch Fondation The Netherland
Not Provided
University Hospital, Montpellier
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP