Facioscapulohumeral Muscular DystrophyFSHDNCT01596803
Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
A study testing Taking of blood, needle biopsy of the vastus lateralis muscle and Vit C Vit E Zn Se in people with Facioscapulohumeral Muscular Dystrophy, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Facioscapulohumeral Muscular Dystrophy
- What is being tested?
- Taking of blood, needle biopsy of the vastus lateralis muscle and Vit C Vit E Zn Se
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2010to 1 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- No consent form
Trial locations and contacts
1 site in 1 country.
France1 site
Montpellier University Hospital- Saint Eloi Hospital
Montpellier, Languedoc-Roussillon, 34294
About this study
Official title: Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)
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.
Read the 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").
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Being tested
- Taking of blood, needle biopsy of the vastus lateralis muscle, Vit C Vit E Zn Se, Placebo Vit E Placebo Vit C Zn Se
- Keywords
- FSHD, Antioxidants, Oxidative stress, Muscle function, Quality of life, Activity, (FSHD;4q35)
- Medical subject headings
- Muscular Dystrophy, Facioscapulohumeral, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking of bloodProcedure or surgery
Taking venous blood samples to analyse oxidant stress
needle biopsy of the vastus lateralis muscleDietary 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 SeDietary supplement
Also called FSHD, Antioxidant
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 Vit E Placebo Vit C Zn SeDietary supplement
venous blood samples and needle biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Taking of blood; Dietary Supplement: needle biopsy of the vastus lateralis muscle; Dietary Supplement: Vit C Vit E Zn Se |
| Placebo | Placebo comparator | Supplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle Receives: Procedure: Taking of blood; Dietary Supplement: needle biopsy of the vastus lateralis muscle; Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: duration study 3 years
Secondary outcomes (2)
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.
Measured: duration study 3 years
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.
Measured: duration study 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study start1 May 2010
- Primary completion20 Feb 2012
- Study completion1 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facioscapulohumeral Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinical Research Project 2010, Association Amis FSH France, FSH Dutch Fondation The Netherland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596803
- Sponsor's protocol ID
- 8426
- Acronym
- FSHD
- Status last verified
- Feb 2020
- First submitted
- 5 Apr 2012
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25246239
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)
- ClinicalTrials.gov ID
- NCT01596803
- Acronym / sponsor ID
- FSHD / 8426
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Keywords
- FSHD, Antioxidants, Oxidative stress, Muscle function, Quality of life, Activity, (FSHD;4q35)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hospital Clinical Research Project 2010, Association Amis FSH France, FSH Dutch Fondation The Netherland
- Study start
- 1 May 2010 (actual)
- Primary completion
- 20 Feb 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamins minerals | Active comparator | Procedure: Taking of blood, Dietary Supplement: needle biopsy of the vastus lateralis muscle, Dietary Supplement: Vit C Vit E Zn SeVitE 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 | Procedure: Taking of blood, Dietary Supplement: needle biopsy of the vastus lateralis muscle, Dietary Supplement: Placebo Vit E Placebo Vit C Zn SeSupplementation 17 weeks placebo venous blood samples (analysis of oxidative stress inflammatory markers) needle biopsy of the vastus lateralis muscle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- FSHD patients will be recruited on the basis of:
Key exclusion criteria (1 listed)
- No consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taking of bloodTaking venous blood samples to analyse oxidant stress | Procedure or surgery | Placebo, vitamins minerals |
| needle biopsy of the vastus lateralis muscleT0 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 | Placebo, vitamins minerals |
| Vit C Vit E Zn SeAlso: FSHD, AntioxidantT0 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 | Dietary supplement | vitamins minerals |
| Placebo Vit E Placebo Vit C Zn Sevenous blood samples and needle biopsy | Dietary supplement | Placebo |
Primary outcome
Improvement of muscle effort tolerance after antioxidant supplementation
Time frame: duration study 3 years
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).
2 secondary outcomes
Changes in inflammatory and oxidative stress parameters after antioxidant supplementation
Time frame: duration study 3 years
Changes in muscular function after antioxidant supplementation
Time frame: duration study 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 25246239Passerieux 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.
Related trials for Facioscapulohumeral Muscular Dystrophy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of SFL-0821 in Adults With FSHD
Facioscapulohumeral Muscular Dystrophy (FSHD)
RecruitingObservational study
Biomarker Development for Muscular Dystrophies
Myotonic Dystrophy, Duchenne Muscular Dystrophy
RecruitingPhase 1
Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)
FSHD - Facioscapulohumeral Muscular Dystrophy
Not yet recruitingPhase 2
A Study of SAT-3247 to Evaluate the Safety, Tolerability, and Efficacy in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)
Facioscapulohumeral Muscular Dystrophy (FSHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taking of blood, needle biopsy of the vastus lateralis muscle and Vit C Vit E Zn Se in people with Facioscapulohumeral Muscular Dystrophy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of muscle effort tolerance after antioxidant supplementation (time frame: duration study 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.