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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-01

Study Completion Date

2012-06-01

Brief Summary

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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.

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Detailed Description

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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").

Conditions

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Facioscapulohumeral Muscular Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Taking of blood

Intervention Type PROCEDURE

Taking venous blood samples to analyse oxidant stress

needle biopsy of the vastus lateralis muscle

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type PLACEBO_COMPARATOR

Taking of blood

Intervention Type PROCEDURE

Taking venous blood samples to analyse oxidant stress

needle biopsy of the vastus lateralis muscle

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Vit E Placebo Vit C Zn Se

Intervention Type DIETARY_SUPPLEMENT

venous blood samples and needle biopsy

Interventions

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Taking of blood

Taking venous blood samples to analyse oxidant stress

Intervention Type PROCEDURE

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Placebo Vit E Placebo Vit C Zn Se

venous blood samples and needle biopsy

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FSHD Antioxidant

Eligibility Criteria

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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