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

Sponsor
Laboratorios Viñas, S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT03000777
Collaborator
Hospital Vall d'Hebron (Other), Laboratorio Echevarne (Other)
60
Enrollment
1
Location
2
Arms
19
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: melatonin plus zinc
  • Other: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Melatonin plus Zinc

Melatonin plus Zinc

Dietary Supplement: melatonin plus zinc
Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks
Other Names:
  • MelatoZinc

    		•
    Placebo Comparator: Placebo

    Isomaltose

    Other: Placebo
    Isomaltose o.d. 1 hour before going to bed during 16 weeks
    Other Names:
  • Control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration [within the first 16 weeks (plus 4 weeks with no treatment)]

    Secondary Outcome Measures

    1. Side effects during treatment. [within the first 16 weeks (plus 4 weeks with no treatment)]

    2. Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire. [within the first 16 weeks (plus 4 weeks with no treatment)]

    3. Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire. [within the first 16 weeks (plus 4 weeks with no treatment)]

    4. Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire. [within the first 16 weeks (plus 4 weeks with no treatment)]

    5. Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire. [within the first 16 weeks (plus 4 weeks with no treatment)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vall d'Hebron University Hospital Barcelona Spain 08035

    Sponsors and Collaborators

    • Laboratorios Viñas, S.A.
    • Hospital Vall d'Hebron
    • Laboratorio Echevarne

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Laboratorios Viñas, S.A.
    ClinicalTrials.gov Identifier:
    NCT03000777
    Other Study ID Numbers:
    • IC/LV/MEL-ZN/SFC
    First Posted:
    Dec 22, 2016
    Last Update Posted:
    Aug 9, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Laboratorios Viñas, S.A.
    melatonin
    zinc
    Myalgic Encephalomyelitis
    Chronic Fatigue Syndrome
    sleep
    pain
    Additional relevant MeSH terms:
    Fatigue Syndrome, Chronic
    Encephalomyelitis
    Myalgia
    Syndrome
    Fatigue
    Melatonin

    Study Results

    No Results Posted as of Aug 9, 2018