NCT03317171: PRO1

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

Completed NA Last updated 25 October 2017

What this trial tests

NA trial testing Flavonoids, DHA, EPA in Muscular Dystrophies in 29 participants. Completed in 31 December 2016.

Timeline

28 February 2016

Primary endpoint
31 December 2016

31 December 2016

Quick facts

Lead sponsor	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	29
Start date	28 February 2016
Primary completion	31 December 2016
Estimated completion	31 December 2016
Sites	1 location across Italy

Drugs / interventions tested

• Flavonoids, DHA, EPA
• placebo compound

Conditions studied

• Muscular Dystrophies — all drugs for Muscular Dystrophies →
• Muscle Inflammation — all drugs for Muscle Inflammation →

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Who can join

Adults 9 to 70, any sex, with Muscular Dystrophies or Muscle Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Sitzia C, Meregalli M, Belicchi M, Farini A, et al · · 2019 · cited 26× · PMID 31396142 · DOI 10.3389/fneur.2019.00755
2. Promising Perspective to Facioscapulohumeral Muscular Dystrophy Treatment: Nutraceuticals and Phytochemicals.
   Hangül C, Karaüzüm SB, Akkol EK, Demir-Dora D, et al · · 2021 · cited 2× · PMID 34315378 · DOI 10.2174/1570159x19666210726151924