Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
NCT03000777 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2018-08-09
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
Conditions
- Fatigue Syndrome, Chronic
- Myalgic Encephalomyelitis
Interventions
- 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
Sponsors & Collaborators
-
Hospital Vall d'Hebron
collaborator OTHER -
Laboratorio Echevarne
collaborator INDUSTRY -
Laboratorios Viñas, S.A.
lead INDUSTRY
Principal Investigators
-
José Alegre, MD; PhD · Vall d'Hebron University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2017-07-31
- Completion
- 2017-09-30
Countries
- Spain
Study Locations
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