20 Participants NeededMy employer runs this trial

VM100 Nutritional Supplement for Duchenne Muscular Dystrophy

TT
Overseen ByTanja Taivassalo
Age: Any Age
Sex: Male
Trial Phase: Phase 2
Sponsor: University of Florida
Must be taking: Glucocorticoids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new nutritional supplement, VM100, can improve the quality of life and physical symptoms for people with Duchenne Muscular Dystrophy (DMD). The researchers focus on the supplement's potential effects on mood, mental clarity, and energy levels. Participants will take the supplement for 10 weeks, with a short break in the middle. Individuals with a confirmed diagnosis of DMD who have maintained a stable medication plan for at least three months may be suitable for the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that VM100 Nutritional Supplement is likely to be safe for humans?

Without specific data about VM100's safety from research sources, assumptions can be made based on the trial phase. This trial is in Phase 2, indicating that VM100 has likely passed initial safety tests in earlier studies. These studies probably demonstrated that the supplement is generally safe for humans.

Phase 2 trials typically focus more on the treatment's effectiveness rather than just its safety. This implies that any serious side effects would have been identified in previous testing. While no treatment is without risk, reaching this phase suggests that VM100 is considered relatively safe for further testing in people.12345

Why do researchers think this study treatment might be promising for Duchenne Muscular Dystrophy?

Unlike the standard of care for Duchenne Muscular Dystrophy, which typically includes corticosteroids like prednisone or deflazacort, the VM100 Nutritional Supplement offers a novel approach by focusing on nutritional support. Researchers are excited about VM100 because it introduces a dietary supplement that aims to support muscle health and potentially improve patient outcomes without the side effects commonly associated with steroids. Additionally, VM100 is administered orally, making it an easy and non-invasive option for patients. This innovative strategy could offer a complementary benefit to existing therapies, providing a more holistic approach to managing the condition.

What evidence suggests that VM100 might be an effective treatment for Duchenne Muscular Dystrophy?

Research has shown that some vitamins, such as nicotinamide riboside, have demonstrated promise in animals for slowing down Duchenne Muscular Dystrophy (DMD). This suggests that certain nutrients might help manage DMD symptoms. Studies on nutritional supplements for DMD have focused on improving muscle function and quality of life. Although the exact ingredients of VM100 remain unspecified, it is designed to support people with DMD. Early results from similar supplements have shown improvements in muscle strength and endurance. This offers hope that VM100, the nutritional supplement tested in this trial, might improve physical symptoms and overall well-being in people with DMD.678910

Who Is on the Research Team?

TT

Tanja Taivassalo, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for people aged 8 and older who have Duchenne Muscular Dystrophy. Participants should be able to take part in a 10-week study testing a nutritional supplement.

Inclusion Criteria

I am 8 years old or older.
I have been on the same dose of my medications for at least 3 months.
I have Duchenne muscular dystrophy confirmed by a genetic test.

Exclusion Criteria

Secondary condition affecting muscle function or metabolism (e.g., myasthenia gravis, endocrine disorders, mitochondrial disease)
Unstable medical conditions or significant concomitant illness
Participation in another investigational clinical trial within the previous 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VM100 nutritional supplement orally twice daily for 10 weeks, consisting of 6 weeks of supplementation, followed by a 2-week washout period without supplementation, and a final 2 weeks of supplementation.

10 weeks
5 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and physical symptoms.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VM100 Nutritional Supplement

Trial Overview

The study tests VM100, a special nutritional supplement, versus a placebo (inactive substance) over 10 weeks. It aims to see if VM100 can improve quality of life, mood, thinking abilities, endurance, and fatigue in people with Duchenne Muscular Dystrophy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: VM100 Nutritional SupplementExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Citations

Current and Potential DMD Treatments Reviewed by Experts

Experts provide an overview of the many treatments to counteract muscle mass loss, inflammation, and fibrosis in Duchenne muscular dystrophy ...

Vamorolone confirms its efficacy over one year in DMD ...

Vamorolone confirms its efficacy over one year in DMD without limiting growth · A total of 121 participants with DMD aged between 4 and 7 years ...

Nutrition Considerations in Duchenne Muscular Dystrophy

When swallowing becomes ineffective, raising the risk of tracheal aspiration, or when malnutrition persists despite calorie-protein ...

Vitamin Could Help Treat Duchenne Muscular Dystrophy

large doses of a vitamin called nicotinamide riboside were remarkably effective in countering the progress of the disease in animals.

Oligonucleotides Provide Hope for the Treatment of ...

However, since muscular dystrophy is caused by defects in certain genes, oligonucleotide therapeutics may be the key to developing effective ...

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