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

University Hospital Center (CHU)

Status: Completed

Conditions: Facioscapulohumeral Muscular Dystrophy

Treatments: 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; Procedure: Taking of blood

Study type: Interventional

Funder types: Other

Identifiers

NCT01596803

8426

Details and patient eligibility

About

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.

Full 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").

Enrollment: 54 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

vitamins minerals

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Vit C Vit E Zn Se

Procedure: Taking of blood

Dietary Supplement: needle biopsy of the vastus lateralis muscle

Placebo

Placebo Comparator group

Description:

Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle

Treatment:

Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se

Procedure: Taking of blood

Dietary Supplement: needle biopsy of the vastus lateralis muscle