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

Not Applicable

Completed

• Conditions: Facioscapulohumeral Muscular Dystrophy
• Interventions: 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

• Registration Number: NCT01596803
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Study Start: 2010-05-01
• Primary Completion: 2012-02-20
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Study Completion: 2012-06-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamins minerals	Vit C Vit E Zn Se	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)
Placebo	needle biopsy of the vastus lateralis muscle	Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle
vitamins minerals	Taking of blood	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)
vitamins minerals	needle biopsy of the vastus lateralis muscle	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)
Placebo	Placebo Vit E Placebo Vit C Zn Se	Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle
Placebo	Taking of blood	Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle

Primary Outcome Measures

Name	Time	Method
Improvement of muscle effort tolerance after antioxidant supplementation	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

Name	Time	Method
Changes in muscular function after antioxidant supplementation	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.
Changes in inflammatory and oxidative stress parameters after antioxidant supplementation	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.

Trial Locations

Locations (1)

Montpellier University Hospital- Saint Eloi Hospital; 🇫🇷 Montpellier, Languedoc-Roussillon, France