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

NCT ID: NCT03317171

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-28

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Muscular Dystrophies Muscle Inflammation

Keywords

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dietary supplementation flavonoids omega 3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treated group

oral administration of flavonoids, DHA and EPA, once a day for 24 weeks.

Group Type EXPERIMENTAL

Flavonoids, DHA, EPA

Intervention Type DIETARY_SUPPLEMENT

oral administration

Placebo group

oral administration of placebo compound, once a day for 24 weeks.

Group Type PLACEBO_COMPARATOR

placebo compound

Intervention Type DIETARY_SUPPLEMENT

oral administration

Interventions

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Flavonoids, DHA, EPA

oral administration

Intervention Type DIETARY_SUPPLEMENT

placebo compound

oral administration

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* documented genetic and histological diagnosis of DMD, FSHD and LGMD;
* absence of severe cardiac and pulmonary disease;
* age superior to 9 years for DMD, between 9 and 70 years for LGMD and between 20 and 70 years for FSHD;
* glucocorticosteroid treatment for 6 or more months (stable dose and regimen for ≥3 months before screening) and for the duration of the study;
* adhesion to inform consent by same patients or parents/tutors for minors.

Exclusion Criteria

* severe cardiac and pulmonary disease;
* positive hepatitis B surface antigen (HBsAg) test, positive hepatitis C and HIV tests;
* low kidney and liver functionality;
* autoimmune disorders;
* mental retardation (IQ via Wechsler Intelligence Scale \< 70);
* psychological-psychiatric disorders; adverse psychosocial conditions;
* known allergies to some of compounds to be used in the trial;
* pathologies occurring just before or during the trial (fever, metabolic disorders, drug abuse);
* enrollment to other trials (steroids regime won't be considered in this list)
Minimum Eligible Age

9 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Countries

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Italy

References

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Sitzia C, Meregalli M, Belicchi M, Farini A, Arosio M, Bestetti D, Villa C, Valenti L, Brambilla P, Torrente Y. Preliminary Evidences of Safety and Efficacy of Flavonoids- and Omega 3-Based Compound for Muscular Dystrophies Treatment: A Randomized Double-Blind Placebo Controlled Pilot Clinical Trial. Front Neurol. 2019 Jul 23;10:755. doi: 10.3389/fneur.2019.00755. eCollection 2019.

Reference Type DERIVED
PMID: 31396142 (View on PubMed)

Other Identifiers

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1768

Identifier Type: -

Identifier Source: org_study_id