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Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

NCT05454683 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2022-07-12

No results posted yet for this study

Summary

The aim of the study is to investigate the effects of oral melatonin and zinc supplementation on core features in individuals with ME/CFS

Conditions

  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis

Interventions

DIETARY_SUPPLEMENT

melatonin plus zinc

One capsule with melatonin 1mg plus zinc 10 mg o.d. 30 minutes before bedtime, at least 1 hour after dinner during 4 months

OTHER

isomaltose and magnesium stearate

One capsule with excipients o.d. 30 minutes before bedtime, at least 1 hour after dinner during 4 months

Sponsors & Collaborators

  • Laboratorio Echevarne

    collaborator INDUSTRY

  • Hospital Vall d'Hebron

    collaborator OTHER

  • 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
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05454683 on ClinicalTrials.gov