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

Laboratorios Viñas, S.A.60 enrolled

Overview

The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fatigue Syndrome, Chronic Myalgic Encephalomyelitis

Interventions

melatonin plus zincDIETARY_SUPPLEMENT

Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks

PlaceboOTHER

Isomaltose o.d. 1 hour before going to bed during 16 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vall d'Hebron University Hospital

Barcelona, Spain

Outcomes

Primary Outcomes

To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration