Hydrogen Water Treatment for Chronic Fatigue Syndrome

NCT05013606 | Completed DMC

• 1 other identifier: H2CFSPilot 1241294
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Keywords

hydrogen; treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pittsburgh Sleep Quality Index

  4 weeks

• Short Form-36 Physical Function Subscale

  4 weeks

• Depression, Anxiety, and Stress Scale

  4 weeks

Other Outcomes (4)

• Heart rate variability

  7 weeks

• Salivary C-Reactive Protein

  6 weeks

• Salivary Uric Acid

  6 weeks

Study Arms (2)

Active Treatment: Hydrogen water

EXPERIMENTAL

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

Dietary Supplement: Hydrogen water

Placebo: Inactive pill

PLACEBO COMPARATOR

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

Dietary Supplement: Hydrogen water

Interventions

Hydrogen water DIETARY_SUPPLEMENT

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

Active Treatment: Hydrogen water; Placebo: Inactive pill

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Water

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pills for both conditions look very similar and each group sees only the pill assigned to that group (H2 or placebo) and not the pill assigned to the other group. Also neither the outcome assessor nor the investigator know which condition that specific individual subjects are assigned to. This is because a blocked randomization schedule of numbers (1s and 2s) is used to assign each consecutive subject enrolled in the study to one of the study conditions. The code that links each subject to an identifiable condition assignment is known only by the PI and not the staff who selects the pills to be sent out to each subject or by the outcomes assessor. Also the subject fills out online outcome forms that involve no interaction with study staff, thus avoiding any staff-specific influence on online outcome forms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: This clinical study involves two groups, one group receiving only the active treatment, hydrogen pills mixed with water, and the other group receiving only a placebo pill mixed with water.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: August 19, 2021
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

US (1)