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

Laboratorios Viñas

Status

Completed

Conditions

Myalgic Encephalomyelitis

Fatigue Syndrome, Chronic

Treatments

Other: Placebo

Dietary Supplement: melatonin plus zinc

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03000777

IC/LV/MEL-ZN/SFC

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.