Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)

An Unicentric, Double-blind, Placebo Controlled, Phase IV Clinical Trial of Oral Melatonin Plus Zinc to Evaluate Relieving Self-reported Fatigue in CFS/ME

The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is a complex medical condition, characterized by severe disabling fatigue with no known cause, no established diagnostic tests, and no universally effective treatment. No studies have evaluated symptomatic treatment using oral melatonin plus zinc supplementation in CFS/ME. The primary endpoint was to assess the effect of melatonin plus zinc supplementation on self-reported fatigue. Secondary measures included self-reported outcomes of sleep problems, anxiety/depression, dysautonomia, QoL and side-effects during treatment.

Inclusion Criteria:

• CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda definition.
• Patient who provided signed informed consent.

Exclusion Criteria:

• Patients who are participating in another clinical trial of the same or different nature previous 30 days prior to inclusion.
• Any subject that, in the judgment of the investigator, is not able to follow the instructions or to perform a good completion of the treatment.
• Subjects that do not provide signed informed consent.
• Patients who are receiving any of the drugs or products that may interfere with the results, and whose withdrawal could be a relevant medical problem.
• Patients receiving oral anticoagulants.
• Pregnancy or lactation
• Patients with hypersensitivity to melatonin and/or zinc.