Hydrogen Water Treatment for Chronic Fatigue Syndrome

NCT ID: NCT05013606

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-06-01

Brief Summary

The proposed placebo-controlled pilot study will examine hydrogen water as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). 25 subjects who meet strict criteria for ME/CFS will be recruited. The 30 day trial will involve subjects ingesting 1-5 8 oz. glasses of hydrogen-dissolved water per day. The placebo condition will involve the same daily ingestion schedule but with an inert placebo pill instead of the active hydrogen treatment pill. The proposed study is intended to establish feasibility of the clinical protocol and examine potential treatment effects of hydrogen water which may include symptom reduction and possibly improved functioning. If feasibility and apparent treatment effects are confirmed, a large clinical trial will be proposed for submission to NIH. In addition to potential therapeutic properties, H2 water is portable, easily administered and safe to ingest.

Self-report assessments for ME/CFS symptoms, fatigue, autonomic symptoms, physical function, anxiety, and depression will be done in the week before and the week after the 30 day trial. In addition, 7-day home-based objective assessments of heart rate variability (a measure of parasympathetic function) and accelerometry (a physical activity assessment) will be scheduled before and after the intervention period.

Detailed Description

SPECIFIC AIMS

The aim of this pilot randomized control trial (RCT) is to explore the possible beneficial effect of a novel therapy, molecular hydrogen (H2) for the symptoms and related functional limitations in patients with chronic fatigue syndrome.

BACKGROUND AND SIGNIFICANCE Oxidative stress and impaired energy metabolism have been implicated in the pathophysiology of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a debilitating illness without clearly identified etiology or effective medical treatments. As such, treatments that reduce oxidative stress and yield improvements in energy production may show potential to ameliorate the symptoms and functional limitations of this illness. Numerous publications on the biological and medical benefits of H2 have shown that H2 reduces oxidative stress not only by direct reactions with strong oxidants, but also indirectly by regulating various gene expressions. In addition to its potential therapeutic properties for ME/CFS, H2 water is portable, easily administered and safe to ingest.

PRELIMINARY STUDIES

The proposed study is a pilot study in ME/CFS for which there are no directly applicable preliminary studies utilizing the proposed H2 therapy.

RESEARCH DESIGN AND METHODS

Eligible subjects will be recruited by advertising. Assessments will be conducted by telephone, via home-based monitoring, and online diaries. The PI has 16 years' experience recruiting ME/CFS patients for his NIH funded studies. Given the absence of effective interventions for this illness and the absence of in-person visits in the proposed study, the possibility of being helped by the benign treatment of H2 is likely to attract many patients with ME/CFS.

Study Sample

Subjects who meet the inclusion/exclusion criteria below and provide consent will be recruited and randomized sequentially 1:1 to receive either H2 or placebo. The investigators will seek to enroll a total of 25 patients meeting enrollment criteria and randomized to H2 vs placebo arms. The investigators project a study duration of 8-10 months.

Screening

Inclusion criteria: These are: patients aged 18-65 of both sexes considered physically capable and willing to perform the study tasks, including wearing a heart monitor and an actigraph (at baseline and post-treatment weeks). Subjects must also meet our validated phone-screen eligibility for ME/ CFS criteria. A physician note confirming a CFS diagnosis will be requested.

Medical exclusions, determined by validated phone screen interview, will consist of 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, as determined by reliable home test kit sent to subjects, is also an exclusion. Two other exclusionary criteria will be used: a) patients on heart medication or patients not dose-stabilized for at least 3 months on antidepressant drugs; b) 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.

Procedures/Outcome measures

This will be a double blinded, placebo-controlled trial. Subjects will be sequentially randomized in a 1:1 ratio to receive H2, or corresponding placebo, additional to all standard-of-care treatments. All study-related participant activities, including questionnaires, activity and heart monitoring, and online diaries will be completed by participants in their homes. No face-to-face visits to Stony Brook are involved. H2 water is Generally Recognized As Safe (GRAS) and is increasingly available on the general consumer market. Self-report questionnaire assessments for ME/CFS symptoms, fatigue, autonomic symptoms, physical function, anxiety, and depression will be done in the week before and the week after the 30 day trial. In addition, an online web diary to record ME/CFS symptoms and home-based objective assessments of heart rate variability (a measure of parasympathetic function) and accelerometry (a physical activity assessment) will be scheduled before, during, and/or after the intervention period.

STATISTICS The study will define improvement by a 50% reduction in ME/CFS symptoms. Repeated measures analysis of variance (ANOVA) will compare pre- and post-treatment measurements of effectiveness and general health markers.

Conditions

Chronic Fatigue Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Treatment: Hydrogen water

Hydrogen pills mixed in a water glass that is ingested up to five time a day for 30 days.

Group Type: EXPERIMENTAL

Hydrogen water

Intervention Type: DIETARY_SUPPLEMENT

This is an over the counter pill supplement that is dissolved in water.

Placebo: Inactive pill

Inactive pills mixed in a water glass that is ingested up to five time a day for 30 days.

Group Type: PLACEBO_COMPARATOR

Hydrogen water

Intervention Type: DIETARY_SUPPLEMENT

This is an over the counter pill supplement that is dissolved in water.

Interventions

Hydrogen water

This is an over the counter pill supplement that is dissolved in water.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Diagnosis of chronic fatigue, chronic fatigue syndrome, ME/CFS or something similar.
• age 21-65

Exclusion Criteria

• Other major medical condition or regular medication that produces fatigue.
• No home computer
• No internet access

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Fred Friedberg

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stony Brook University

Stony Brook, New York, United States

Countries

United States

Other Identifiers

H2CFSPilot 1241294

Identifier Type: -

Identifier Source: org_study_id