Routine Health Care of Patients With FSHD

NCT ID: NCT02622438

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-19
• Study Completion Date: 2024-07-03

Brief Summary

On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.

Detailed Description

This study will assess course of patients with FSHD in accordance with usual care performed within the Department of clinical physiology at the University hospital of Montpellier. This prospective longitudinal study include an initial assessment. Then the follow up of patients will be monitored at 12 months and annually. The eventual objective will be to develop a FSHD disease cohort in care at the Montpellier hospital. A statistical analysis will be performed at 3-years follow-up

Conditions

Primary Disease Fascioscapulohumeral Dystrophy (FSHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Course and follow up of patients affected by FSHD

Group Type: OTHER

Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient.

Intervention Type: OTHER

Interventions

Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Molecular and clinical diagnosis for FSHD
• patients, men and women aged > 7 years,

Exclusion Criteria

• pregnant women
• Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
• Major protected by law (guardianship, curatorship or under judicial protection)

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques MERCIER, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Montpellier

Locations

Montpellier University Hospital- Saint Eloi Hospital

Montpellier, Languedoc-Roussillon, France

Countries

France

Other Identifiers

9371

Identifier Type: -

Identifier Source: org_study_id