Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Chronic Fatigue Syndrome (CFS)
In brief
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 facts
- Study ID
- NCT07753122
- Run by
- Fred Friedberg
- People needed
- 80
- Starts
- 2026-08-15
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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…
- 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. Kidney disease/renal failure is also an exclusion
- 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 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.
Where it is running
- Stony Brook University — Stony Brook, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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