Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Unknown statusNot applicableNCT05454683
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The aim of the study is to investigate the effects of oral melatonin and zinc supplementation on core features in individuals with ME/CFS
Study details
- Official title
- Effect of Melatonin Plus Zinc Supplementation on Fatigue, Pain, Sleep Disturbances, Anxiety and Depression, and Autonomic Dysfunction in ME/CFS: a Randomized, Double-blind, Placebo-controlled Study
- Conditions
- Chronic Fatigue Syndrome
- Myalgic Encephalomyelitis
- Interventions
- Dietary supplement: melatonin plus zinc
- Other: isomaltose and magnesium stearate
- Sponsor
- Laboratorios Viñas, S.A.
- Collaborators
- Laboratorio Echevarne; Hospital Vall d'Hebron
- Start date
- 2022-09-05
- Primary completion
- 2024-09-30
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patients between 18 and 65 years of age. 2. Patients with ME/CFS who met the diagnostic criteria (2011 ICC criteria) from the Central Sensitization Syndrome Unit (USSC) at the Vall d'Hebron University Hospital. 3. Patients who freely give written consent. Exclusion Criteria: 1. Any active medical condition that explained chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, medication side-effects). 2. Previous diagnosis not unequivocally resolved (chronic hepatitis, malignancy). 3. Past or current psychiatric disorders (major depressive disorder with psychotic or melancholic features, bipolar disorder, schizophrenia, delusional disorder, dementias, anorexia nervosa, bulimia nervosa). 4. Participation in another clinical trial of the same or different nature in the 30 days prior to study inclusion. 5. In the judgment of the investigator, inability to follow the instructions or to complete the treatment satisfactorily. 6. Failure to provide signed informed consent. 7. Current consumption of medications that may interfere with the results and/or whose withdrawal may be a relevant problem. 8. Anticoagulant treatment. 9. Pregnancy or breast-feeding, or had not used oral contraceptives or other hormonal preparations in the previous 6 months. 10. Smoking, alcohol intake or substance abuse. 11. Severe obesity (class 3 BMI ≥ 40 kg/m2). 12. Hypersensitivity to melatonin and/or zinc dietary supplements.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05454683