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

NCT01596803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-02-12

No results posted yet for this study

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

Interventions

PROCEDURE

Taking of blood

Taking venous blood samples to analyse oxidant stress

DIETARY_SUPPLEMENT

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

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

DIETARY_SUPPLEMENT

Placebo Vit E Placebo Vit C Zn Se

venous blood samples and needle biopsy

Sponsors & Collaborators

  • Hospital Clinical Research Project 2010

    collaborator UNKNOWN

  • Association Amis FSH France

    collaborator UNKNOWN

  • FSH Dutch Fondation The Netherland

    collaborator UNKNOWN

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-01
Primary Completion
2012-02-20
Completion
2012-06-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596803 on ClinicalTrials.gov