Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo condition, Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks..
- Who it may be relevant to
- Registry conditions: Chronic Fatigue Syndrome (CFS). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial of Moderate Dose Hydrogen Water as a Treatment for ME/CFS
Overview
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.
Detailed description
The purpose of this pilot randomized controlled trial is (1) to more definitively test for the efficacy of hydrogen water as a treatment for chronic fatigue syndrome (CFS) and (2) identify and confirm a cardio-autonomic biomarker for improvement in chronic fatigue syndrome. Treatment of chronic fatigue syndrome will start with a 10-day graduated dosing schedule followed by a standard daily dose of hydrogen water (a magnesium-based OTC supplement) over 16 weeks. We expect the active treatment condition to show significant improvements in fatigue and physical function in comparison to the placebo control condition. The treatment outcomes will also be examined for the presence of two subgroups: improvers and non-improvers. These subgroups will be delineated by heart rate variability (HRV), a biological measure of health and well-being. Higher HRV will predict improvement and lower HRV will predict non-improvement (no change or worsening). This would be the first biomarker of improvement found in chronic fatigue syndrome. If treatment is successful, subjects will experience a reduction in fatigue and an increase in physical function. Thus, the study may advance potentially an effective intervention for individuals with CFS and further the understanding of the biology of favorable treatment outcomes, i.e., improved HRV status.
Interventions
- Dietary supplement Placebo condition
16 week intervention of magnesium pill without active ingredient of molecular hydrogen. - Dietary supplement Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.
The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.
Primary outcome measures
- Fatigue Severity Scale [Time frame: 2 weeks.]
Secondary outcome measures (3)
- SF-36 Physical Function Subscale [Time frame: 30 days]
- Depression, Anxiety and Stress Scale [Time frame: 30 days]
- Hassles and Uplifts Scale [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- 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
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. 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stony Brook University — Stony Brook
Identifiers
NCT: NCT07753122 · IRB2026-00236