Trial | NCT01596803  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin e vitamin c zinc selenium ...

  • Study Participants

    54
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").
Study Started
May 01
2010
Primary Completion
Feb 20
2012
Study Completion
Jun 01
2012
Last Update
Feb 12
2020

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

vitamins minerals Active Comparator

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 Comparator

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

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
No Results Posted