Safety and Efficacy of a Flavonoids- and omega3s-based Compound for the Treatment of Muscular Dystrophies

Not Applicable

Completed

• Conditions: Muscular Dystrophies; Muscle Inflammation
• Interventions: Dietary Supplement: placebo compound; Dietary Supplement: Flavonoids, DHA, EPA

• Registration Number: NCT03317171
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

The study aimed to assess the safety and, partially, the efficacy of dietary supplementation of a flavonoids-, DHA- and EPA-based natural supplement in non-ambulant DMD boys and in a cohort of LGMD and FSHD patients to compare its effect in MDs of different aetiology and to eventually highlight any differences in inflammatory involved pathways. To assess safety, patient's laboratory parameters were monitored and adverse events recorded, while efficacy was evaluated through performance scale questionnaire and strength measurement (6 minute walking test and Biodex System 4 Dynamometer parameter evaluation). This study was conceived as proof of principle for the safe use of flavonoids/omega3s-based compound as an adjuvant in the management of neuromuscular disorders; besides, its efficacy in alleviating symptoms linked to secondary effects of genetic mutation as inflammation, muscular pain and weakness was assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-28
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-23
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	placebo compound	oral administration of placebo compound, once a day for 24 weeks.
Treated group	Flavonoids, DHA, EPA	oral administration of flavonoids, DHA and EPA, once a day for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Safety of the administered supplements	month 0 and month +6	neurological clinical assessment, to monitor any possible change before and after the study

Secondary Outcome Measures

Name	Time	Method
Efficacy outcome - functional changes after the treatment	month 0, month +2, month +4, month +6	ABILHAND (manual ability for adults with upper limb impairments) scale. The scale measures manual ability for adults with upper limb impairments.Min. score: 0 - max. score 36

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 MIlan, Italy