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

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ClinicalTrials.gov Identifier: NCT03000777
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Laboratorio Echevarne
Information provided by (Responsible Party):
Laboratorios Viñas, S.A.

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
Fatigue Syndrome, Chronic Myalgic Encephalomyelitis Dietary Supplement: melatonin plus zinc Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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 Name: MelatoZinc

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




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 [ Time Frame: within the first 16 weeks (plus 4 weeks with no treatment) ]

Secondary Outcome Measures :
  1. Side effects during treatment. [ Time Frame: within the first 16 weeks (plus 4 weeks with no treatment) ]
  2. Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: within the first 16 weeks (plus 4 weeks with no treatment) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000777


Locations
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Spain
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Laboratorios Viñas, S.A.
Hospital Vall d'Hebron
Laboratorio Echevarne
Investigators
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Principal Investigator: José Alegre, MD; PhD Vall d'Hebron University Hospital

Publications:

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Responsible Party: Laboratorios Viñas, S.A.
ClinicalTrials.gov Identifier: NCT03000777     History of Changes
Other Study ID Numbers: IC/LV/MEL-ZN/SFC
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Myalgia
Encephalomyelitis
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections
Musculoskeletal Pain
Pain
Neurologic Manifestations
Zinc
Melatonin
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants