Hydrogen Water Dosing Study for ME/CFS

NCT06227273 | Unknown DMC

• 1 other identifier: 41245
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this 16-week pilot randomized trial is to explore the potential benefit of the OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Methods: This 16-week home-based trial will compare two groups: (1) low dose hydrogen water (2-3 glasses/day) for all 16 weeks; and (2) low dose followed by high dose hydrogen water (up to 5 glasses/day). Condition (2) involves an initial 8 weeks of low dose H2 followed by 8 weeks of high dose H2 in order to test the premise that the higher dosage will be more effective with fewer adverse effects if preceded by several weeks of low dose H2. Outcomes measures will include online assessments of fatigue, physical function and stress. A salivary biomarker for oxidative stress, Uric Acid, will also be assessed.

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• Fatigue Severity Scale

  Self-report measure of effect of fatigue on functioning.

  16 weeks

Secondary Outcomes (2)

• SF-36 PF

  16 weeks

• Depression, Anxiety and Stress Scale

  16 weeks

Study Arms (2)

H2 Standard Dose

ACTIVE COMPARATOR

This condition will schedule 1-5 glasses of hydrogen water a day for 16 weeks.

Dietary Supplement: Hydrogen water

H2 Standard Dose followed by Higher Dose H2

ACTIVE COMPARATOR

This condition will schedule 1-5 glasses of hydrogen water a day for 8 weeks followed by 4-5 glasses of hydrogen water for 8 weeks.

Dietary Supplement: Hydrogen water

Interventions

Hydrogen water DIETARY_SUPPLEMENT

Daily consumption of hydrogen water for 16 weeks.

H2 Standard Dose; H2 Standard Dose followed by Higher Dose H2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients aged 18-65 of both sexes; considered physically capable and willing to perform the study tasks.
• Meeting validated phone-screen eligibility for ME/CFS criteria.
• Patient has internet and computer.

You may not qualify if:

• Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS.
• Patients with BMI\>35.
• Patients at significant risk of suicide or in need of urgent psychiatric treatment. As much as possible, appropriate medical and psychiatric referrals to facilities local to subjects will be provided.

Sponsors & Collaborators

• Stony Brook University: lead
• Natural Wellness Now Health Products: collaborator

Study Sites (1)

Fred Friedberg

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Water

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Fred Friedberg, PhD

CONTACT

631-638-1931; fred.friedberg@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator is blinded to computer-generated condition assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two different 16-week dosing schedules will be compared: A standard dose of hydrogen water as compared to a standard dose followed by an increased dose of hydrogen water.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: December 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

US (1)