Hydrogen Water Treatment for Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

— H2CFS  

Official title:

Hydrogen Water as a Treatment for Chronic Fatigue Syndrome: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013606
• Other study ID #: H2CFSPilot 1241294
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2021
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Dietary Supplement:
• Hydrogen water
This is an over the counter pill supplement that is dissolved in water.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate variability	Objective measure of autonomic function	7 weeks
Other	Salivary C-Reactive Protein	This commonly used objective marker of systemic inflammation can be assessed in salivary samples.	6 weeks
Other	Salivary Uric Acid	Salivary uric acid is a measure of antioxidant status.	6 weeks
Other	Salivary Alpha Amylase	This digestive enzyme appears to be a reliable marker of sympathetic nervous activity	6 weeks
Primary	Fatigue Severity Scale	Fatigue Severity Scale; Minimum value=1; Maximum value=7; Range: 1.00-7.00. Higher scores indicate a worse outcome.	4 weeks
Secondary	Pittsburgh Sleep Quality Index	Self-report measure of sleep quality; A patient's seven subscores, each of which can range from 0 to 3 are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.	4 weeks
Secondary	Short Form-36 Physical Function Subscale	Self-report measure of physical functioning. The Short Form 36 physical function subscale is composed of ten items encompassing a hierarchical range of difficulties. Each item is scored on the basis of the limitations perceived by surveyed individuals. Item scores (1, 2, or 3) are summed to obtain a total score, which can then be scaled relative to its range. Higher scores indicate higher physical function.	4 weeks
Secondary	Depression, Anxiety, and Stress Scale	Self-report measure of depression, anxiety and stress symptoms; This 21-item stress measure contains three seven-item subscales: anxiety, depression and stress. Domain scores are calculated by summing all items in a domain and multiplying by two.; Scores range from 0-37+ on each subscale with higher scores indicated greater symptom severity.	4 weeks