Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Part of paid clinical trials in Stony Brook, New York.
- Sponsor
- Fred Friedberg
- Study ID
- NCT07753122
- Status
- Recruiting
Conditions
- Chronic Fatigue Syndrome (CFS)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Placebo condition — DIETARY_SUPPLEMENT16 week intervention of magnesium pill without active ingredient of molecular hydrogen.
- Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks. — DIETARY_SUPPLEMENTThe 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.
Study Details
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.
Key Dates
- First listed
- Aug 7, 2026
- Start date
- Aug 15, 2026
- Status verified
- Jun 2026
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Placebo conditionMagnesium tablet, 3 tablets a day dissolved in water, without active ingredient of molecular hydrogen. 16 week duration.
- Experimental: Active hydrogen water intervention
Primary Outcome Measure
Fatigue Severity Scale [ Time Frame: 2 weeks. ]
Central Contacts
- Fred Friedberg, PhD16316381931
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stony Brook University | Stony Brook | New York | 11794-6000 |
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