Status:
COMPLETED
Safety and Efficacy of a Flavonoids- and omega3s-based Compound for the Treatment of Muscular Dystrophies
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Muscular Dystrophies
Muscle Inflammation
Eligibility:
All Genders
9-70 years
Phase:
NA
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 an...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03317171
Start Date
February 28 2016
End Date
December 31 2016
Last Update
October 25 2017
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122