Clinical trial NCT01596803: Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
Official title: Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facioscapulohumeral Muscular Dystrophy
Keywords: FSHD
Antioxidants
Oxidative stress
Muscle function
Quality of life
Activity
(FSHD;4q35)
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Hospital Clinical Research Project 2010
name: Association Amis FSH France
name: FSH Dutch Fondation The Netherland
First posted: 2012-05-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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").

Eligibility 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

Primary outcomes:
measure: Improvement of muscle effort tolerance after antioxidant supplementation
timeFrame: duration study 3 years
Secondary outcomes:
measure: Changes in inflammatory and oxidative stress parameters after antioxidant supplementation
timeFrame: duration study 3 years
measure: Changes in muscular function after antioxidant supplementation
timeFrame: duration study 3 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital- Saint Eloi Hospital
state: Languedoc-Roussillon
Study officials:
References:
citation: Passerieux E, Hayot M, Jaussent A, Carnac G, Gouzi F, Pillard F, Picot MC, Bocker K, Hugon G, Pincemail J, Defraigne JO, Verrips T, Mercier J, Laoudj-Chenivesse D. Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial. Free Radic Biol Med. 2015 Apr;81:158-69. doi: 10.1016/j.freeradbiomed.2014.09.014. Epub 2014 Sep 20.