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

Primary Purpose

Fatigue Syndrome, Chronic, Myalgic Encephalomyelitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
melatonin plus zinc
Placebo
Sponsored by
Laboratorios Viñas, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue Syndrome, Chronic focused on measuring melatonin, zinc, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, sleep, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda definition.
  • Patient who provided signed informed consent.

Exclusion Criteria:

  • Patients who are participating in another clinical trial of the same or different nature previous 30 days prior to inclusion.
  • Any subject that, in the judgment of the investigator, is not able to follow the instructions or to perform a good completion of the treatment.
  • Subjects that do not provide signed informed consent.
  • Patients who are receiving any of the drugs or products that may interfere with the results, and whose withdrawal could be a relevant medical problem.
  • Patients receiving oral anticoagulants.
  • Pregnancy or lactation
  • Patients with hypersensitivity to melatonin and/or zinc.

Sites / Locations

  • Vall d'Hebron University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin plus Zinc

Placebo

Arm Description

Melatonin plus Zinc

Isomaltose

Outcomes

Primary Outcome Measures

To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration

Secondary Outcome Measures

Side effects during treatment.
Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire.
Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire.

Full Information

First Posted
December 19, 2016
Last Updated
August 8, 2018
Sponsor
Laboratorios Viñas, S.A.
Collaborators
Hospital Vall d'Hebron, Laboratorio Echevarne
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1. Study Identification

Unique Protocol Identification Number
NCT03000777
Brief Title
Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
Acronym
MELATOZINC
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Viñas, S.A.
Collaborators
Hospital Vall d'Hebron, Laboratorio Echevarne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue Syndrome, Chronic, Myalgic Encephalomyelitis
Keywords
melatonin, zinc, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, sleep, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin plus Zinc
Arm Type
Experimental
Arm Description
Melatonin plus Zinc
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Isomaltose
Intervention Type
Dietary Supplement
Intervention Name(s)
melatonin plus zinc
Other Intervention Name(s)
MelatoZinc
Intervention Description
Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Isomaltose o.d. 1 hour before going to bed during 16 weeks
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Side effects during treatment.
Time Frame
within the first 16 weeks (plus 4 weeks with no treatment)
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda definition. Patient who provided signed informed consent. Exclusion Criteria: Patients who are participating in another clinical trial of the same or different nature previous 30 days prior to inclusion. Any subject that, in the judgment of the investigator, is not able to follow the instructions or to perform a good completion of the treatment. Subjects that do not provide signed informed consent. Patients who are receiving any of the drugs or products that may interfere with the results, and whose withdrawal could be a relevant medical problem. Patients receiving oral anticoagulants. Pregnancy or lactation Patients with hypersensitivity to melatonin and/or zinc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Alegre, MD; PhD
Organizational Affiliation
Vall d'Hebron University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23600892
Citation
Castro-Marrero J, Cordero MD, Saez-Francas N, Jimenez-Gutierrez C, Aguilar-Montilla FJ, Aliste L, Alegre-Martin J. Could mitochondrial dysfunction be a differentiating marker between chronic fatigue syndrome and fibromyalgia? Antioxid Redox Signal. 2013 Nov 20;19(15):1855-60. doi: 10.1089/ars.2013.5346. Epub 2013 May 29.
Results Reference
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PubMed Identifier
25386668
Citation
Castro-Marrero J, Cordero MD, Segundo MJ, Saez-Francas N, Calvo N, Roman-Malo L, Aliste L, Fernandez de Sevilla T, Alegre J. Does oral coenzyme Q10 plus NADH supplementation improve fatigue and biochemical parameters in chronic fatigue syndrome? Antioxid Redox Signal. 2015 Mar 10;22(8):679-85. doi: 10.1089/ars.2014.6181. Epub 2014 Dec 18.
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PubMed Identifier
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Citation
Castro-Marrero J, Saez-Francas N, Segundo MJ, Calvo N, Faro M, Aliste L, Fernandez de Sevilla T, Alegre J. Effect of coenzyme Q10 plus nicotinamide adenine dinucleotide supplementation on maximum heart rate after exercise testing in chronic fatigue syndrome - A randomized, controlled, double-blind trial. Clin Nutr. 2016 Aug;35(4):826-34. doi: 10.1016/j.clnu.2015.07.010. Epub 2015 Jul 17.
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PubMed Identifier
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Citation
Saez-Francas N, Calvo N, Alegre J, Castro-Marrero J, Ramirez N, Hernandez-Vara J, Casas M. Childhood trauma in Chronic Fatigue Syndrome: focus on personality disorders and psychopathology. Compr Psychiatry. 2015 Oct;62:13-9. doi: 10.1016/j.comppsych.2015.06.010. Epub 2015 Jun 17.
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PubMed Identifier
26190206
Citation
Faro M, Saez-Francas N, Castro-Marrero J, Aliste L, Fernandez de Sevilla T, Alegre J. Gender differences in chronic fatigue syndrome. Reumatol Clin. 2016 Mar-Apr;12(2):72-7. doi: 10.1016/j.reuma.2015.05.007. Epub 2015 Jul 17. English, Spanish.
Results Reference
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PubMed Identifier
25812543
Citation
Calvo N, Saez-Francas N, Valero S, Alegre J, Casas M. Comorbid personality disorders in chronic fatigue syndrome patients: a marker of psychopathological severity. Actas Esp Psiquiatr. 2015 Mar-Apr;43(2):58-65. Epub 2015 Mar 1.
Results Reference
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PubMed Identifier
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Citation
Faro M, Alegre J. [Fibromyalgia as a comorbid phenomenon in autoinflammatory diseases]. Med Clin (Barc). 2015 Jun 8;144(11):525. doi: 10.1016/j.medcli.2014.07.033. Epub 2014 Nov 26. No abstract available. Spanish.
Results Reference
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PubMed Identifier
24826505
Citation
Santamarina-Perez P, Eiroa-Orosa FJ, Rodriguez-Urrutia A, Qureshi A, Alegre J. Neuropsychological impairment in female patients with chronic fatigue syndrome: a preliminary study. Appl Neuropsychol Adult. 2014;21(2):120-7. doi: 10.1080/09084282.2013.771264. Epub 2013 Aug 13.
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PubMed Identifier
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Citation
Saez-Francas N, Valero S, Calvo N, Goma-I-Freixanet M, Alegre J, de Sevilla TF, Casas M. Chronic fatigue syndrome and personality: a case-control study using the Alternative Five Factor Model. Psychiatry Res. 2014 May 30;216(3):373-8. doi: 10.1016/j.psychres.2014.02.031. Epub 2014 Mar 3.
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PubMed Identifier
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Citation
Docampo E, Escaramis G, Gratacos M, Villatoro S, Puig A, Kogevinas M, Collado A, Carbonell J, Rivera J, Vidal J, Alegre J, Estivill X, Rabionet R. Genome-wide analysis of single nucleotide polymorphisms and copy number variants in fibromyalgia suggest a role for the central nervous system. Pain. 2014 Jun;155(6):1102-1109. doi: 10.1016/j.pain.2014.02.016. Epub 2014 Feb 26.
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Citation
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PubMed Identifier
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Results Reference
derived

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

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