Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Официальное название

Randomized Controlled Trial of Moderate Dose Hydrogen Water as a Treatment for ME/CFS

Обзор

This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME/CFS observational study.

Подробное описание

The purpose of this pilot randomized controlled trial is (1) to more definitively test for the efficacy of hydrogen water as a treatment for chronic fatigue syndrome (CFS) and (2) identify and confirm a cardio-autonomic biomarker for improvement in chronic fatigue syndrome. Treatment of chronic fatigue syndrome will start with a 10-day graduated dosing schedule followed by a standard daily dose of hydrogen water (a magnesium-based OTC supplement) over 16 weeks. We expect the active treatment condition to show significant improvements in fatigue and physical function in comparison to the placebo control condition. The treatment outcomes will also be examined for the presence of two subgroups: improvers and non-improvers. These subgroups will be delineated by heart rate variability (HRV), a biological measure of health and well-being. Higher HRV will predict improvement and lower HRV will predict non-improvement (no change or worsening). This would be the first biomarker of improvement found in chronic fatigue syndrome. If treatment is successful, subjects will experience a reduction in fatigue and an increase in physical function. Thus, the study may advance potentially an effective intervention for individuals with CFS and further the understanding of the biology of favorable treatment outcomes, i.e., improved HRV status.

Вмешательства

• Пищевая добавка Placebo condition
  16 week intervention of magnesium pill without active ingredient of molecular hydrogen.
• Пищевая добавка Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.
  The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.

Первичные конечные точки

• Fatigue Severity Scale [Срок оценки: 2 weeks.]

Вторичные конечные точки (3)

• SF-36 Physical Function Subscale [Срок оценки: 30 days]
• Depression, Anxiety and Stress Scale [Срок оценки: 30 days]
• Hassles and Uplifts Scale [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• Patients aged 18-65 of both sexes
• considered physically capable and willing to perform the study tasks
• Meet validated phone-screen eligibility for ME/CFS criteria
• Participant has internet and computer

Критерии исключения

• 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. Kidney disease/renal failure is also an exclusion
• 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 regularly taking therapeutic magnesium.

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stony Brook University — Stony Brook

Идентификаторы

NCT: NCT07753122 · IRB2026-00236

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗