Recruiting
Phase 2

VM100

Sponsor:

University of Florida

Code:

NCT07766980

Conditions

Duchenne Muscular Dystrophy

Duchenne Disease

Muscular Dystrophy in Children

DMD

Muscular Dystrophy

Eligibility Criteria

Sex: Male

Age: 6+

Healthy Volunteers: Not accepted

Interventions

VM100 Nutritional Supplement

Study Details

Brief 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).

Conditions

Duchenne Muscular Dystrophy

Duchenne Disease

Muscular Dystrophy in Children

DMD

Muscular Dystrophy

Study ID

NCT07766980

Start date

Jul 27, 2026

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 6+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VM100 Nutritional Supplement

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.

Interventions

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.

Primary outcome measure

  • Changes in DMD Quality of Life Physical Symptoms Domain Score [ Time Frame: Baseline, Weeks 2, 6, 8, and 10 ]
  • Changes in Mental Wellbeing assessed Warwick-Edinburgh Mental Well-being Scale Score [ 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 [ Time Frame: Baseline, Weeks 2, 6, 8, and 10 ]

Central Contacts and Locations

Central contacts

Tanja Taivassalo

(352) 294 - 8748ttaivassalo@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Tanja Taivassalo

352-294-8748ttaivassalo@ufl.edu

Principal Investigator:

Tanja Taivassalo

More Information

Sponsor

University of Florida

Last update posted

Oct 8, 2026

Last verified

Oct, 2025

Keywords

  • DMD
  • Nutritional supplement
  • Quality of life
  • Cognitive function
  • Fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by University of Florida on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.