Evaluating VM100 Nutritional Supplement for Improving Quality of Life in Duchenne Muscular Dystrophy Patients

NCT07766980 | Recruiting

• 1 other identifier: IRB202401626
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, Weeks 2, 6, 8, and 10

Secondary Outcomes (7)

• Changes in Cognitive Function assessed by Trail Making Test.

  Baseline and Week 6; Week 10 if the assessment is conducted

• Changes in Cognitive Function assessed by Controlled Oral Word Association (COWA) Test

  Baseline and Week 6; Week 10 if the assessment is conducted

• Blood Concentration of Comprehensive Metabolic Panel

  Baseline and Week 6

• Blood Concentration of Creatine Kinase

  Baseline and Week 6

• Blood Concentration of Complete Blood Count

  Baseline and Week 6

Study Arms (1)

VM100 Nutritional Supplement

EXPERIMENTAL

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.

Dietary Supplement: VM100 Nutritional Supplement

Interventions

VM100 Nutritional Supplement DIETARY_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

VM100 Nutritional Supplement

Eligibility Criteria

• Age: 6 Years+
• Gender Eligibility Details: Yes Duchenne Muscular Dystrophy is an X-linked disorder, and therefore predominantly in males. As a result, the principal investigator is limiting the children study participants to males.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Tabes Dorsalis; Muscular Dystrophies; Fatigue

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurosyphilis; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Syphilis; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Spinal Cord Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanja Taivassalo, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Taivassalo

CONTACT

(352) 294 - 8748; ttaivassalo@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 17, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2025-10

Locations

US (1)