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

NCT01596803 | Completed DMC

• 1 other identifier: 8426
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Facioscapulohumeral Muscular Dystrophy

Keywords

FSHD; Antioxidants; Oxidative stress; Muscle function; Quality of life; Activity; (FSHD;4q35)

Outcome Measures

Primary Outcomes (1)

• 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).

  duration study 3 years

Secondary Outcomes (2)

• Changes in inflammatory and oxidative stress parameters after antioxidant supplementation

  duration study 3 years

• Changes in muscular function after antioxidant supplementation

  duration study 3 years

Study Arms (2)

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)

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

Procedure: Taking of blood; Dietary Supplement: needle biopsy of the vastus lateralis muscle; Dietary Supplement: Placebo Vit E Placebo Vit C Zn Se

Interventions

Taking of blood PROCEDURE

Taking venous blood samples to analyse oxidant stress

Placebo; vitamins minerals

needle biopsy of the vastus lateralis muscle 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; vitamins minerals

Vit C Vit E Zn Se 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

Also known as: FSHD, Antioxidant

vitamins minerals

Placebo Vit E Placebo Vit C Zn Se DIETARY_SUPPLEMENT

venous blood samples and needle biopsy

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• No consent form

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Hospital Clinical Research Project 2010: collaborator
• Association Amis FSH France: collaborator
• FSH Dutch Fondation The Netherland: collaborator

Study Sites (1)

Montpellier University Hospital- Saint Eloi Hospital

Montpellier, Languedoc-Roussillon, 34294, France

Location

Related Publications (1)

• 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.

  PMID: 25246239 DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Facioscapulohumeral; Motor Activity

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: May 11, 2012
• Study Start: May 1, 2010
• Primary Completion: February 20, 2012
• Study Completion: June 1, 2012
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

FR (1)