VM100 Nutritional Supplement for Duchenne Muscular Dystrophy
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and physical symptoms.
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
Participants will 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Citations
1.
musculardystrophynews.com
musculardystrophynews.com/news/duchenne-muscular-dystrophy-treatments-both-current-and-potential-reviewed-by-experts/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 ...
2.
institut-myologie.org
institut-myologie.org/en/research/vamorolone-confirms-its-efficacy-over-one-year-in-dmd-without-limiting-growth/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 ...
3.
researchgate.net
researchgate.net/publication/276356960_Nutrition_Considerations_in_Duchenne_Muscular_DystrophyNutrition Considerations in Duchenne Muscular Dystrophy
When swallowing becomes ineffective, raising the risk of tracheal aspiration, or when malnutrition persists despite calorie-protein ...
4.
drugdiscoverytrends.com
drugdiscoverytrends.com/vitamin-could-help-treat-duchenne-muscular-dystrophy/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.
5.
oligotherapeutics.org
oligotherapeutics.org/oligonucleotides-provide-hope-for-the-treatment-of-duchenne-muscular-dystrophy/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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