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NCT07766980
Evaluating VM100 Nutritional Supplement for Improving Quality of Life in Duchenne Muscular Dystrophy Patients
Conditions: Duchenne Muscular Dystrophy, Duchenne Disease, Muscular Dystrophy in Children, DMD, Muscular Dystrophy
Sex: Male
Ages: 6 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: University of Florida
Location: University of Florida Gainesville Florida
Summary
This pilot study will investigate the potential efficacy of VM100, a nutritional supplement specifically formulated for patients with DMD, on quality of life and physical symptoms. Twenty patients (aged 8 an over) will be enrolled to undergo a 10-week placebo-controlled intervention with VM100. Outcomes will include validated questionnaires and qualitative interview to assess impact on mental, cognitive and mood related measures, as well as endurance and fatigue).
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of DMD confirmed by genetic report
* Age 8 years or older.
* Stable glucocorticoid and/or other medication regimen for at least 3 months before enrollment and throughout study participation.
Exclusion Criteria:
* Unstable medical conditions or significant concomitant illness.
* Secondary condition affecting muscle function or metabolism (e.g., myasthenia gravis, endocrine disorders, mitochondrial disease).
* Participation in another investigational clinical trial within the previous 3 months.
Source: ClinicalTrials.gov (NCT07766980). StuddyBuddy aggregates publicly available trial information.