Hydrogen Water Dosing Study for ME/CFS
Status unconfirmed · Not applicable
Conditions studied: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
In brief
The aim of this 16-week pilot randomized trial is to explore the potential benefit of the OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Methods: This 16-week home-based trial will compare two groups: (1) low dose hydrogen water (2-3 glasses/day) for all 16 weeks; and (2) low dose followed by high dose hydrogen water (up to 5 glasses/day). Condition (2) involves an initial 8 weeks of low dose H2 followed by 8 weeks of high dose H2 in order to test the premise that the higher dosage will be more effective with fewer adverse effects if preceded by several weeks of low dose H2. Outcomes measures will include online assessments of fatigue, physical function and stress. A salivary biomarker for oxidative stress, Uric Acid, will also be assessed.
Key facts
- Study ID
- NCT06227273
- Run by
- Stony Brook University
- People needed
- 50
- Starts
- 2023-12-01
- Expected to finish
- 2024-11-30
- Last updated by the study team
- 2024-01-26
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.
- Meeting validated phone-screen eligibility for ME/CFS criteria.
- Patient 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.
- __ 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 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
- Fred Friedberg — Stony Brook, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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