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

Not Applicable

Completed

• Conditions: Myalgic Encephalomyelitis; Fatigue Syndrome, Chronic
• Interventions: Other: Placebo; Dietary Supplement: melatonin plus zinc

• Registration Number: NCT03000777
• Lead Sponsor: 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

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-22
• Primary Completion: 2017-07
• Study Completion: 2017-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Isomaltose
Melatonin plus Zinc	melatonin plus zinc	Melatonin plus Zinc

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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)
Side effects during treatment.	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)

Trial Locations

Locations (1)

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain