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

Facioscapulohumeral Muscular Dystrophy Clinical Trial

— FSHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596803
• Other study ID #: 8426
• Status: Completed
• Phase: N/A
• Start date: May 1, 2010
• Est. completion date: June 1, 2012

Study information

• Verified date: February 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 1, 2012
• Est. primary completion date: February 20, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Facioscapulohumeral Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral

Intervention

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
• 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
• Placebo Vit E Placebo Vit C Zn Se
venous blood samples and needle biopsy

Locations

Country	Name	City	State
France	Montpellier University Hospital- Saint Eloi Hospital	Montpellier	Languedoc-Roussillon

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Association Amis FSH France, FSH Dutch Fondation The Netherland, Hospital Clinical Research Project 2010

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of muscle effort tolerance after antioxidant supplementation	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).	duration study 3 years
Secondary	Changes in inflammatory and oxidative stress parameters after antioxidant supplementation	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.	duration study 3 years
Secondary	Changes in muscular function after antioxidant supplementation	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.	duration study 3 years