ClinicalTrials.gg
RecruitingNCT07753122ME/CFSUpdated Aug 7, 2026

Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

An interventional study of Placebo condition and Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks. in Chronic Fatigue Syndrome (CFS), sponsored by Fred Friedberg. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Fred Friedberg · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 86 studies in Fatigue Syndrome, Chronic with a site in United States — 21 open to participants now, 24 under way, none of them phase 3. Fatigue Syndrome, Chronic · United States.

Planned enrollment
19th of 58
80 · median 50
Started
2026
with 6 others
No phase
30 of 86
6 open now
Primary completion
2027-07
later than 13 of 23 live
Registered
85th of 86
by date

Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, this one is the 19th largest by planned enrollment of the 58 interventional ones that give a count, is one of 7 that started in 2026, is one of 30 with no phase, reaches primary completion later than 13 of the 23 other live ones, and was the 85th registered.

Fatigue Syndrome, Chronic

264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.

Browse Fatigue Syndrome, Chronic studies →

Open to participants now

21 of the 86 studies in Fatigue Syndrome, Chronic with a site in United States are open now. Recruiting first, the newest first:

15 more — sign in →

All 21 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 86 studies in Fatigue Syndrome, Chronic with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Chronic Fatigue Syndrome (CFS)

Keywords

  • chronic fatigue syndrome; myalgic encephelomyelitis; ME/CFS; hydrogen water; treatment; biomarker heart rate variability
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 >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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    Placebo condition

    Magnesium tablet, 3 tablets a day dissolved in water, without active ingredient of molecular hydrogen. 16 week duration.

    Dietary Supplement: Placebo condition

  • Experimental
    Active hydrogen water intervention

    Dietary Supplement: Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.

Interventions

  • Dietary supplementPlacebo condition

    16 week intervention of magnesium pill without active ingredient of molecular hydrogen.

  • Dietary supplementMolecular 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.

06

What researchers measure

Primary outcomes

  1. Fatigue Severity Scale

    Self-report measure of the effect of fatigue on functioning.

    Time frame: 2 weeks.

Secondary outcomes

  1. SF-36 Physical Function Subscale

    Self-report measure of how much health limits your ability to perform various types of physical activities.

    Time frame: 30 days

  2. Depression, Anxiety and Stress Scale

    Self-report measures three related negative emotional states of depression, anxiety, and tension/stress.

    Time frame: 30 days

  3. Hassles and Uplifts Scale

    Self-report measure of chronic minor stressors and positive everyday experiences.

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.

Of 73 non-industry interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 11 months is below that.

Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Aug 7, 2026
StartEst.
Aug 15, 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07753122
Lead sponsor
Fred Friedberg
Responsible party
Fred Friedberg (Principal Investigator, Stony Brook University) — Sponsor-investigator
First posted
Aug 7, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Aug 7, 2026

Study contacts

Fred Friedberg, PhD
Contact
Fred.Friedberg@stonybrookmedicine.edu
16316381931
Fred Friedberg, PhD
principal investigator · Stony Brook University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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