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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Laboratorios Viñas, S.A.

Current Primary Outcome: To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration [ Time Frame: within the first 16 weeks (plus 4 weeks with no treatment) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Laboratorios Viñas, S.A.

Dates:
Date Received: December 19, 2016
Date Started: February 2016
Date Completion: October 2017
Last Updated: December 19, 2016
Last Verified: December 2016