Recruiting

Hydrogen Water

Sponsor:

Stony Brook University

Code:

NCT06227273

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Hydrogen water

Study Details

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

Study ID

NCT06227273

Start date

Dec 1, 2023

Status verified date

Jan, 2024

Completion date

Nov 30, 2024

Anticipated

Primary completion date

Nov 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

- 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.

Exclusion Criteria:

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.

__ Exclusionary psychiatric disorders include any psychosis, or alcohol/ substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME/CFS or anytime afterward

  • Pregnancy is an exclusion.
  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: H2 Standard Dose

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

active comparator: H2 Standard Dose followed by Higher Dose H2

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.

Interventions

Hydrogen water

Daily consumption of hydrogen water for 16 weeks.

Primary outcome measure

  • Fatigue Severity Scale [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Fred Friedberg, PhD

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

Locations

Fred Friedberg

Recruiting

Stony Brook, New York, United States, 11794

Contacts

FRED FRIEDBERG, PhD

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

Principal Investigator:

Fred Friedberg, PhD

More Information

Sponsor

Stony Brook University

Last update posted

Jan 26, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Stony Brook University on 2024-01-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.