Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD) (FSHD)
Primary Purpose
Facioscapulohumeral Muscular Dystrophy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Taking of blood
needle biopsy of the vastus lateralis muscle
Vit C Vit E Zn Se
Placebo Vit E Placebo Vit C Zn Se
Sponsored by
About this trial
This is an interventional supportive care trial for Facioscapulohumeral Muscular Dystrophy focused on measuring FSHD, Antioxidants, Oxidative stress, Muscle function, Quality of life, Activity, (FSHD;4q35)
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
Sites / Locations
- Montpellier University Hospital- Saint Eloi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
vitamins minerals
Placebo
Arm 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)
Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01596803
First Posted
April 5, 2012
Last Updated
February 11, 2020
Sponsor
University Hospital, Montpellier
Collaborators
Hospital Clinical Research Project 2010, Association Amis FSH France, FSH Dutch Fondation The Netherland
1. Study Identification
Unique Protocol Identification Number
NCT01596803
Brief Title
Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
Acronym
FSHD
Official Title
Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
February 20, 2012 (Actual)
Study Completion Date
June 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Hospital Clinical Research Project 2010, Association Amis FSH France, FSH Dutch Fondation The Netherland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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").
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facioscapulohumeral Muscular Dystrophy
Keywords
FSHD, Antioxidants, Oxidative stress, Muscle function, Quality of life, Activity, (FSHD;4q35)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamins minerals
Arm Type
Active Comparator
Arm 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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle
Intervention Type
Procedure
Intervention Name(s)
Taking of blood
Intervention Description
Taking venous blood samples to analyse oxidant stress
Intervention Type
Dietary Supplement
Intervention Name(s)
needle biopsy of the vastus lateralis muscle
Intervention Description
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
Intervention Name(s)
Vit C Vit E Zn Se
Other Intervention Name(s)
FSHD, Antioxidant
Intervention Description
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
Intervention Name(s)
Placebo Vit E Placebo Vit C Zn Se
Intervention Description
venous blood samples and needle biopsy
Primary Outcome Measure Information:
Title
Improvement of muscle effort tolerance after antioxidant supplementation
Description
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).
Time Frame
duration study 3 years
Secondary Outcome Measure Information:
Title
Changes in inflammatory and oxidative stress parameters after antioxidant supplementation
Description
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.
Time Frame
duration study 3 years
Title
Changes in muscular function after antioxidant supplementation
Description
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.
Time Frame
duration study 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Montpellier University Hospital- Saint Eloi Hospital
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34294
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25246239
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.
Results Reference
derived
Learn more about this trial
Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
We'll reach out to this number within 24 hrs