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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fatigue Syndrome, Chronic, Myalgic Encephalomyelitis

Intervention / Treatment
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* Dietary Supplement: melatonin plus zinc
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin plus Zinc<br>Melatonin plus Zinc | Dietary Supplement: melatonin plus zinc<br>* Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks<br>* Other names: MelatoZinc;|
| Placebo Comparator: Placebo<br>Isomaltose | Other: Placebo<br>* Isomaltose o.d. 1 hour before going to bed during 16 weeks<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects during treatment. |  | within the first 16 weeks (plus 4 weeks with no treatment) | 
| Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire. |  | within the first 16 weeks (plus 4 weeks with no treatment) | 
| Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire. |  | within the first 16 weeks (plus 4 weeks with no treatment) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, zinc, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, sleep, pain