NCT03000777

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Laboratorios Viñas, S.A. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fatigue Syndrome, Chronic
• Myalgic Encephalomyelitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	melatonin plus zinc	Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks
OTHER	Placebo	Isomaltose o.d. 1 hour before going to bed during 16 weeks

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2016-12-22
• Last updated: 2018-08-09

Locations

1 site across 1 country: Spain