VM100: a nutritional supplement to see if it improves quality of life for boys with Duchenne

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled pilot study to evaluate the preliminary efficacy of VM100 in improving quality of life and physical symptoms in boys with Duchenne muscular dystrophy. Twenty participants will take VM100 or placebo for 10 weeks at home, with twice-daily dosing. Outcomes include validated questionnaires and qualitative interviews assessing mental, cognitive, mood, social behavior, endurance, and fatigue. Daily compliance and participant experiences will be collected through caregiver-reported surveys and interviews at multiple time points. The study is conducted primarily at the University of Florida facilities with remote aspects for home-based administration.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Tanja Taivassalo, MD — University of Florida
• Study coordinator: Tanja Taivassalo
• Email: ttaivassalo@ufl.edu
• Phone: (352) 294 - 8748

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.