Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
ME/CFS
Randomized Controlled Trial of Moderate Dose Hydrogen Water as a Treatment for ME/CFS
1 other identifier
interventional
80
1 country
1
Brief Summary
This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME/CFS observational study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2026
CompletedFirst Posted
Study publicly available on registry
August 7, 2026
CompletedStudy Start
First participant enrolled
August 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
August 7, 2026
June 1, 2026
11 months
August 3, 2026
August 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue Severity Scale
Self-report measure of the effect of fatigue on functioning.
2 weeks.
Secondary Outcomes (3)
SF-36 Physical Function Subscale
30 days
Depression, Anxiety and Stress Scale
30 days
Hassles and Uplifts Scale
2 weeks
Study Arms (2)
Placebo condition
PLACEBO COMPARATORMagnesium tablet, 3 tablets a day dissolved in water, without active ingredient of molecular hydrogen. 16 week duration.
Active hydrogen water intervention
EXPERIMENTALInterventions
The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.
16 week intervention of magnesium pill without active ingredient of molecular hydrogen.
Eligibility Criteria
You may qualify if:
- Patients aged 18-65 of both sexes
- considered physically capable and willing to perform the study tasks
- Meet validated phone-screen eligibility for ME/CFS criteria
- Participant has internet and computer
You may not qualify if:
- Patients with BMI\>35
- \_\_\_\_Patients regularly taking therapeutic magnesium.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Friedberglead
Study Sites (1)
Stony Brook University
Stony Brook, New York, 11794-6000, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fred Friedberg, PhD
Stony Brook University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 3, 2026
First Posted
August 7, 2026
Study Start
August 15, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
August 7, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share