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

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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

Interventional


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.

Condition

Fatigue Syndrome, Chronic

Intervention

melatonin plus zinc

Study Arms / Comparison Groups

 Melatonin plus Zinc
Description:  Melatonin plus Zinc

Publications

* 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

60

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
             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.
      

Gender

Female

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

José Alegre, MD; PhD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT03000777

Organization ID

IC/LV/MEL-ZN/SFC


Responsible Party

Sponsor

Study Sponsor

Laboratorios Viñas, S.A.

Collaborators

 Hospital Vall d'Hebron

Study Sponsor

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


Verification Date

August 2018