A Phase 2 interventional study of VM100 Nutritional Supplement in Duchenne Muscular Dystrophy, Duchenne Disease and Muscular Dystrophy in Children, sponsored by University of Florida. Recruiting at 1 site in United States. Open to male participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
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).
Ongoing efforts at therapeutic development for Duchenne muscular dystrophy (DMD) are aimed at genetic and pharmacologic strategies to mitigate muscle damage and loss of strength. However there is also an important and largely overlooked need to improve general mental and physical quality of life of DMD patients. It is estimated that between 20% to 80% of DMD patients use vitamins or nutritional supplements, but there is very little research on their efficacy. This may relate in part to poor bioavailability (the extent and rate at which active ingredients are absorbed and utilized by the body). This exploratory trial will investigate the preliminary efficacy of VM100, a nutritional supplement in boys with DMD. VM100 contains a combination of 10 ingredients specially formulated into a drink to increase absorption and bioavailability, and developed to support pathophysiology of DMD (inflammation, mitochondrial impairment, oxidative stress) in both skeletal muscle and brain.
This study is predominantly home-based, where patients will take VM100 in the form of a drink, twice a day. Patients and their parent or caregiver will be asked to fill out a daily survey of supplement compliance, as well as questionnaires and an interview 5 times over the course of the study. These questionnaires will assess the impact of VM100 on quality of life for boys with DMD, with a focus on mental, cognitive, mood and social behavior-related measures, as well as physical symptoms such as endurance and general fatigue. Two blood draws will be obtained (before and 6 weeks after taking VM100) to assess impact on proinflammatory cytokines and markers of muscle damage. Pilot data generated from this study will be used to support a more robust, placebo-controlled trial including objective outcome measures and assessing potential of VM100 to synergize with other therapeutics.
481 studies on the registry are indexed under Muscular Dystrophy, Duchenne; 108 are open to participants now.
This study's planned enrollment of 20 is below the median of 26 across 332 interventional studies indexed under Muscular Dystrophy, Duchenne.
Browse Muscular Dystrophy, Duchenne studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: VM100 Nutritional Supplement
VM100 is an investigational dietary supplement formulated specifically for individuals with Duchenne muscular dystrophy. It contains ten naturally derived ingredients formulated using a proprietary technology to enhance bioavailability. The supplement is intended to support mitochondrial function, reduce inflammation and oxidative stress, improve cognitive function and mood, and promote overall quality of life. Participants will self-administer the supplement orally twice daily during the intervention period.
Also known as: VM100
Changes in DMD Quality of Life Physical Symptoms Domain Score
Duchenne Muscular Dystrophy Quality of Life (DMD-QoL) Physical Symptoms Domain Score, as measured by the validated DMD-QoL questionnaire. Scores will be reported according to the scoring system of the DMD-QoL instrument.
Time frame: Baseline, Weeks 2, 6, 8, and 10
Changes in Mental Wellbeing assessed Warwick-Edinburgh Mental Well-being Scale Score
Total score on the Warwick-Edinburgh Mental Well-being Scale, a 14- or 7-item caregiver-reported measure of positive mental well-being, including optimism, energy, clear thinking, and social connectedness. Items are scored on a 1-5 scale.
Time frame: Baseline, Weeks 2, 6, 8, and 10
Changes in Quality of Life assessed by PedsQL 4.0 Short Form (SF-15) Total Score
Total score on the PedsQL 4.0 Short Form (SF-15), Acute Version, completed by child self-report and parent proxy report. The questionnaire includes Physical, Emotional, Social, and School Functioning domains and assesses functioning over the previous 7 days.
Time frame: Baseline, Weeks 2, 6, 8, and 10
Changes in Cognitive Function assessed by Trail Making Test.
Time required to complete the Trail Making Test, measured in seconds.
Time frame: Baseline and Week 6; Week 10 if the assessment is conducted
Changes in Cognitive Function assessed by Controlled Oral Word Association (COWA) Test
Total number of acceptable words generated during the Controlled Oral Word Association (COWA) Test within the specified time period.
Time frame: Baseline and Week 6; Week 10 if the assessment is conducted
Blood Concentration of Comprehensive Metabolic Panel
Determined laboratory values from the comprehensive metabolic panel, including measures of metabolic and organ function, obtained from blood samples.
Time frame: Baseline and Week 6
Blood Concentration of Creatine Kinase
Determine blood concentration of creatine kinase (CK), a biomarker of muscle damage, measured using analysis of blood samples.
Time frame: Baseline and Week 6
Blood Concentration of Complete Blood Count
Determine laboratory values from the complete blood count with differential obtained from blood samples.
Time frame: Baseline and Week 6
Total Cycling Time and Distance During Moderate-Intensity Cycle Exercise
Total cycling time and distance achieved during a moderate-intensity cycle exercise test using a recumbent cycle ergometer or Rifton adaptive tricycle.
Time frame: Baseline and Week 6; Week 10 if the assessment is conducted
Percentage of Prescribed VM100 Doses Taken
Percentage of prescribed VM100 doses taken during the study, calculated from daily compliance logs recorded by participants' parents or caregivers using the study REDCap database.
Time frame: Throughout the 10-week study
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Muscular Dystrophy, Duchenne →