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

Learn more about:
Related Clinical Trial
Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis Complex Chronic Diseases Program Data Registry Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy The Exercise Response to Pharmacologic Cholinergic Stimulation in Preload Failure Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome The Comeback Study New MRT Imaging Biomarkers and Treatment With Kinetic Oscillatory Stimulation (KOS) in Nasal Cavity for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS

Brief Title

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

Official Title

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

Brief Summary

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

Detailed Description

      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.

Study Type


Primary Outcome

To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration

Secondary Outcome

 Side effects during treatment.


Fatigue Syndrome, Chronic


melatonin plus zinc

Study Arms / Comparison Groups

 Melatonin plus Zinc
Description:  Melatonin plus Zinc


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Dietary Supplement

Estimated Enrollment


Start Date

February 2016

Completion Date

September 2017

Primary Completion Date

July 2017

Eligibility Criteria

        Inclusion Criteria:

          -  CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda

          -  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.




18 Years - 65 Years

Accepts Healthy Volunteers



José Alegre, MD; PhD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Laboratorios Viñas, S.A.


 Hospital Vall d'Hebron

Study Sponsor

José Alegre, MD; PhD, Principal Investigator, Vall d'Hebron University Hospital

Verification Date

August 2018