Clinical trial NCT03000777: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Myalgic Encephalomyelitis
Keywords: melatonin
zinc
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
sleep
pain
Lead sponsor: Laboratorios Viñas, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Vall d'Hebron
name: Laboratorio Echevarne
First posted: 2016-12-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration
timeFrame: within the first 16 weeks (plus 4 weeks with no treatment)
Secondary outcomes:
measure: Side effects during treatment.
timeFrame: within the first 16 weeks (plus 4 weeks with no treatment)
measure: Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
timeFrame: within the first 16 weeks (plus 4 weeks with no treatment)
measure: Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.
timeFrame: within the first 16 weeks (plus 4 weeks with no treatment)
measure: Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire.
timeFrame: within the first 16 weeks (plus 4 weeks with no treatment)
measure: Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire.
timeFrame: within the first 16 weeks (plus 4 weeks with no treatment)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
Study officials:
affiliation: Vall d'Hebron University Hospital
name: José Alegre, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
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