RECRUITING

Hydrogen Water Dosing Study for ME/CFS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Hydrogen Water Dosing Study for ME/CFS and Chronic Fatigue

Quick Facts

Study Start:2023-12-01
Study Completion:2024-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06227273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meeting validated phone-screen eligibility for ME/CFS criteria.
  2. * Patient has internet and computer.
  1. * Pregnancy is an exclusion.
  2. * Patients with BMI\>35.
  3. * 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.

Contacts and Locations

Study Contact

Fred Friedberg, PhD
CONTACT
631-638-1931
fred.friedberg@stonybrookmedicine.edu

Study Locations (Sites)

Fred Friedberg
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: Stony Brook University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2024-11-30

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2024-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome