Back to resultsMelatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MelatoZincME)
Primary Purpose
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
melatonin plus zinc
isomaltose and magnesium stearate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring melatonin, zinc, fatigue, sleep quality, quality of life, pain, anxiety and depression, actigraphy, heart rate variability, orthostatic intolerance
Eligibility Criteria
Inclusion Criteria:
- Patients between 18 and 65 years of age.
- 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.
- Patients who freely give written consent.
Exclusion Criteria:
- Any active medical condition that explained chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, medication side-effects).
- Previous diagnosis not unequivocally resolved (chronic hepatitis, malignancy).
- Past or current psychiatric disorders (major depressive disorder with psychotic or melancholic features, bipolar disorder, schizophrenia, delusional disorder, dementias, anorexia nervosa, bulimia nervosa).
- Participation in another clinical trial of the same or different nature in the 30 days prior to study inclusion.
- In the judgment of the investigator, inability to follow the instructions or to complete the treatment satisfactorily.
- Failure to provide signed informed consent.
- Current consumption of medications that may interfere with the results and/or whose withdrawal may be a relevant problem.
- Anticoagulant treatment.
- Pregnancy or breast-feeding, or had not used oral contraceptives or other hormonal preparations in the previous 6 months.
- Smoking, alcohol intake or substance abuse.
- Severe obesity (class 3 BMI ≥ 40 kg/m2).
- Hypersensitivity to melatonin and/or zinc dietary supplements.
Sites / Locations
- Vall d'Hebron University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Melatonin plus Zinc
Placebo
Arm Description
Dietary Supplement: 53 patients treated with melatonin 1 mg plus Zinc 10 mg
53 patients treated with isomaltose and magnesium stearate (excipients)
Outcomes
Primary Outcome Measures
Self-reported fatigue as assessed by the 40-item Fatigue Impact Scale (FIS-40) over the baseline in the study participants.
The FIS-40 includes three subscales of the perceived impact of fatigue: cognitive (10 items), physical (10 items) and psychosocial functions (20 items), each item being scored from 0 (no fatigue) to 4 (severe fatigue). The total score is calculated by adding together the responses from the 40 questions (range 0-160). Higher scores indicate more functional limitations due to fatigue.
Secondary Outcome Measures
The health-related quality of life (HRQoL) as assessed by the Short-Form 36-Item Health Survey (SF-36) over the baseline in the study participants.
The SF-36 is a broadly-based self-reported survey on health-related physical and mental functioning status. It assesses functioning on eight subscales, including domains of physical functioning, physical role, bodily pain, general health, social functioning, vitality, emotional role and mental health, and two general subscales covering the physical and mental health domains on a 0-100 score. Lower scores indicate a more negative impact of an individual's health on functioning.
Sleep disturbances as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire over the baseline in the study participants.
The PSQI is the self-administered 19-item questionnaire. PSQI scores are obtained on each of seven components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep perturbations, use of sleeping medication and daytime dysfunction. Each item is scored from 0 to 3 (0 = no sleep problems and 3 = severe sleep problems). The global PSQI score ranges from 0 to 21 points, with scores of >5 indicating poorer sleep quality.
Sleepiness as assessed by the Epworth Sleepiness Scale (ESS) over the baseline in the study participants.
The ESS is a short, self-administered questionnaire that consists of eight questions asking to rate how likely it is to fall asleep in everyday situations (each question can be scored from 0 to 3 points: '0' indicates no sleepiness, and '3' indicates significant sleepiness). It provides a total score which has been shown to relate to the subject's level of daytime sleepiness (total score is ranging from 0 to 24 points).
Sleep latency as assessed by an actigraph sensor over the baseline in the study participants.
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device was programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables were recorded and stored in the device's memory for data analysis.
Sleep onset as assessed by an actigraph sensor over the baseline in the study participants
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Sleep efficiency as assessed by an actigraph sensor over the baseline in the study participants.
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Total sleep time as assessed by an actigraph sensor over the baseline in the study participants.
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Wake time as assessed by an actigraph sensor over the baseline in the study participants.
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Number of awakenings as assessed by an actigraph sensor over the baseline in the study participants.
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Heart rate variability (HRV) as recorded by the FitLab software over the baseline in the study participants.
Changes in the cardiovagal autonomic dysfuntion will be continuously assessed and recorded for the R-R intervals over 5-min periods at rest and in the supine position on different days using the FitLab software.
Orthostatic intolerance as assessed by the active standing test (10-minute NASA Lean test) over the baseline in the study participants.
The 10-minute NLT is a well-established non-invasive procedure used to assess impaired cardiovascular responses to standing and to diagnose OI phenotypes. It records objective hemodynamic parameters (blood pressure and heart rate). The participants will be first asked to lie down during 5 minutes and then to stand and lean against a wall, with heels 6-8 inches from the wall. Throughout the recording, participants will be asked to remain motionless, quiet and any talking or movement will be discouraged, except for reporting any symptoms of concern.
Pain intensity as assessed by a visual analog scale (VAS) over the baseline in the study participants.
The pain VAS is a continuous and unidimensional measure of pain intensity. It comprised of a horizontal line of 10-centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. "No pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain"(score of 10).
Anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS) over the baseline in the study participants.
The HADS is a validated self-reported tool composed of 14 items (seven related to anxiety symptoms and seven to depression). Each item is scored from 0-3, and thus, scores range from 0 to 21; scores of 0-7 are interpreted as normal, 8-10 as mild, 11-14 as moderate, and 15-21 as severe for either anxiety or depression. The total HADS score ranges from 0 (no anxiety or depression) to 42 (severe anxiety and depression).
Side effect of treatment
Treatment side effects will be collected from each participant during clinical trial.
Full Information
NCT ID
NCT05454683
First Posted
June 30, 2022
Last Updated
July 7, 2022
Sponsor
Laboratorios Viñas, S.A.
Collaborators
Laboratorio Echevarne, Hospital Vall d'Hebron
1. Study Identification
Unique Protocol Identification Number
NCT05454683
Brief Title
Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Acronym
MelatoZincME
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Viñas, S.A.
Collaborators
Laboratorio Echevarne, Hospital Vall d'Hebron
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed Description
Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome (ME/CFS) is a heterogeneous condition characterized mainly by debilitating and prolonged fatigue, post-exertional malaise (physical, mental and emotional), unrefreshing sleep, cognitive impairment, and orthostatic intolerance with prolonged recovery that is not relieved by rest. Currently, the etiopathogenic mechanisms of ME/CFS are unknown. At present, there is no diagnostic test or effective treatment. MelatoZinc is a food supplement composed of melatonin and zinc, which could contribute to the circadian rhythm homeostasis and regulation of redox imbalance and immune response.
The aim is to evaluate the efficacy and safety of oral treatment with MelatoZinc on the symptomatic complex of fatigue in a larger Spanish ME/CFS population.
This is a single-center, randomized, double-blind, placebo controlled clinical trial. It will include a total of 106 ME/CFS patients who met 2011 ICC criteria for ME/CFS. All patients will take one capsule daily for 16 weeks. Group A will receive MelatoZinc (1 mg melatonin plus 10 mg zinc), and group B will receive a placebo (excipients: isomaltose and magnesium stearate). Clinical symptoms will be evaluated, and standardized questionnaires will be applied to assess the impact of fatigue, pain, anxiety-depression symptoms, sleep quality, dysautonomia, and quality of life. Heart rate variability (HRV) and orthostatic intolerance (10-min NASA Lean Test) will be performed to evaluate autonomic dysfunction. Sleep efficiency will be estimated through an actigraph sensor
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Keywords
melatonin, zinc, fatigue, sleep quality, quality of life, pain, anxiety and depression, actigraphy, heart rate variability, orthostatic intolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin plus Zinc
Arm Type
Experimental
Arm Description
Dietary Supplement:
53 patients treated with melatonin 1 mg plus Zinc 10 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
53 patients treated with isomaltose and magnesium stearate (excipients)
Intervention Type
Dietary Supplement
Intervention Name(s)
melatonin plus zinc
Other Intervention Name(s)
MelatoZinc
Intervention Description
One capsule with melatonin 1mg plus zinc 10 mg o.d. 30 minutes before bedtime, at least 1 hour after dinner during 4 months
Intervention Type
Other
Intervention Name(s)
isomaltose and magnesium stearate
Other Intervention Name(s)
excipients
Intervention Description
One capsule with excipients o.d. 30 minutes before bedtime, at least 1 hour after dinner during 4 months
Primary Outcome Measure Information:
Title
Self-reported fatigue as assessed by the 40-item Fatigue Impact Scale (FIS-40) over the baseline in the study participants.
Description
The FIS-40 includes three subscales of the perceived impact of fatigue: cognitive (10 items), physical (10 items) and psychosocial functions (20 items), each item being scored from 0 (no fatigue) to 4 (severe fatigue). The total score is calculated by adding together the responses from the 40 questions (range 0-160). Higher scores indicate more functional limitations due to fatigue.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Secondary Outcome Measure Information:
Title
The health-related quality of life (HRQoL) as assessed by the Short-Form 36-Item Health Survey (SF-36) over the baseline in the study participants.
Description
The SF-36 is a broadly-based self-reported survey on health-related physical and mental functioning status. It assesses functioning on eight subscales, including domains of physical functioning, physical role, bodily pain, general health, social functioning, vitality, emotional role and mental health, and two general subscales covering the physical and mental health domains on a 0-100 score. Lower scores indicate a more negative impact of an individual's health on functioning.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Sleep disturbances as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire over the baseline in the study participants.
Description
The PSQI is the self-administered 19-item questionnaire. PSQI scores are obtained on each of seven components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep perturbations, use of sleeping medication and daytime dysfunction. Each item is scored from 0 to 3 (0 = no sleep problems and 3 = severe sleep problems). The global PSQI score ranges from 0 to 21 points, with scores of >5 indicating poorer sleep quality.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Sleepiness as assessed by the Epworth Sleepiness Scale (ESS) over the baseline in the study participants.
Description
The ESS is a short, self-administered questionnaire that consists of eight questions asking to rate how likely it is to fall asleep in everyday situations (each question can be scored from 0 to 3 points: '0' indicates no sleepiness, and '3' indicates significant sleepiness). It provides a total score which has been shown to relate to the subject's level of daytime sleepiness (total score is ranging from 0 to 24 points).
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Sleep latency as assessed by an actigraph sensor over the baseline in the study participants.
Description
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device was programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables were recorded and stored in the device's memory for data analysis.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Sleep onset as assessed by an actigraph sensor over the baseline in the study participants
Description
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Sleep efficiency as assessed by an actigraph sensor over the baseline in the study participants.
Description
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Total sleep time as assessed by an actigraph sensor over the baseline in the study participants.
Description
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Wake time as assessed by an actigraph sensor over the baseline in the study participants.
Description
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Number of awakenings as assessed by an actigraph sensor over the baseline in the study participants.
Description
An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Heart rate variability (HRV) as recorded by the FitLab software over the baseline in the study participants.
Description
Changes in the cardiovagal autonomic dysfuntion will be continuously assessed and recorded for the R-R intervals over 5-min periods at rest and in the supine position on different days using the FitLab software.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Orthostatic intolerance as assessed by the active standing test (10-minute NASA Lean test) over the baseline in the study participants.
Description
The 10-minute NLT is a well-established non-invasive procedure used to assess impaired cardiovascular responses to standing and to diagnose OI phenotypes. It records objective hemodynamic parameters (blood pressure and heart rate). The participants will be first asked to lie down during 5 minutes and then to stand and lean against a wall, with heels 6-8 inches from the wall. Throughout the recording, participants will be asked to remain motionless, quiet and any talking or movement will be discouraged, except for reporting any symptoms of concern.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Pain intensity as assessed by a visual analog scale (VAS) over the baseline in the study participants.
Description
The pain VAS is a continuous and unidimensional measure of pain intensity. It comprised of a horizontal line of 10-centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. "No pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain"(score of 10).
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS) over the baseline in the study participants.
Description
The HADS is a validated self-reported tool composed of 14 items (seven related to anxiety symptoms and seven to depression). Each item is scored from 0-3, and thus, scores range from 0 to 21; scores of 0-7 are interpreted as normal, 8-10 as mild, 11-14 as moderate, and 15-21 as severe for either anxiety or depression. The total HADS score ranges from 0 (no anxiety or depression) to 42 (severe anxiety and depression).
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
Title
Side effect of treatment
Description
Treatment side effects will be collected from each participant during clinical trial.
Time Frame
During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 18 and 65 years of age.
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.
Patients who freely give written consent.
Exclusion Criteria:
Any active medical condition that explained chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, medication side-effects).
Previous diagnosis not unequivocally resolved (chronic hepatitis, malignancy).
Past or current psychiatric disorders (major depressive disorder with psychotic or melancholic features, bipolar disorder, schizophrenia, delusional disorder, dementias, anorexia nervosa, bulimia nervosa).
Participation in another clinical trial of the same or different nature in the 30 days prior to study inclusion.
In the judgment of the investigator, inability to follow the instructions or to complete the treatment satisfactorily.
Failure to provide signed informed consent.
Current consumption of medications that may interfere with the results and/or whose withdrawal may be a relevant problem.
Anticoagulant treatment.
Pregnancy or breast-feeding, or had not used oral contraceptives or other hormonal preparations in the previous 6 months.
Smoking, alcohol intake or substance abuse.
Severe obesity (class 3 BMI ≥ 40 kg/m2).
Hypersensitivity to melatonin and/or zinc dietary supplements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Alegre, MD, PhD
Phone
+34934893000
Ext
3753
Email
jalegre@vhebron.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jesús Castro, PhD
Phone
+34934893000
Ext
3753
Email
jesus.castro@vhir.org
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Alegre, MD; PhD
Phone
+34934893000
Ext
4927
Email
jalegre@vhebron.net
First Name & Middle Initial & Last Name & Degree
Jesús Castro, PhD
Phone
+34934893000
Ext
4927
Email
jesus.castro@vhir.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34201806
Citation
Castro-Marrero J, Zaragoza MC, Lopez-Vilchez I, Galmes JL, Cordobilla B, Maurel S, Domingo JC, Alegre-Martin J. Effect of Melatonin Plus Zinc Supplementation on Fatigue Perception in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Antioxidants (Basel). 2021 Jun 23;10(7):1010. doi: 10.3390/antiox10071010.
Results Reference
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35229657
Citation
Castro-Marrero J, Domingo JC, Cordobilla B, Ferrer R, Giralt M, Sanmartin-Sentanes R, Alegre-Martin J. Does Coenzyme Q10 Plus Selenium Supplementation Ameliorate Clinical Outcomes by Modulating Oxidative Stress and Inflammation in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? Antioxid Redox Signal. 2022 Apr;36(10-12):729-739. doi: 10.1089/ars.2022.0018.
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34575280
Citation
Castro-Marrero J, Zacares M, Almenar-Perez E, Alegre-Martin J, Oltra E. Complement Component C1q as a Potential Diagnostic Tool for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Subtyping. J Clin Med. 2021 Sep 15;10(18):4171. doi: 10.3390/jcm10184171.
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Castro-Marrero J, Segundo MJ, Lacasa M, Martinez-Martinez A, Sentanes RS, Alegre-Martin J. Effect of Dietary Coenzyme Q10 Plus NADH Supplementation on Fatigue Perception and Health-Related Quality of Life in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2021 Jul 30;13(8):2658. doi: 10.3390/nu13082658.
Results Reference
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PubMed Identifier
34300271
Citation
Baklund IH, Dammen T, Moum TA, Kristiansen W, Duarte DS, Castro-Marrero J, Helland IB, Strand EB. Evaluating Routine Blood Tests According to Clinical Symptoms and Diagnostic Criteria in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. J Clin Med. 2021 Jul 14;10(14):3105. doi: 10.3390/jcm10143105.
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PubMed Identifier
34071326
Citation
Capdevila L, Castro-Marrero J, Alegre J, Ramos-Castro J, Escorihuela RM. Analysis of Gender Differences in HRV of Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Using Mobile-Health Technology. Sensors (Basel). 2021 May 28;21(11):3746. doi: 10.3390/s21113746.
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Citation
Domingo JC, Cordobilla B, Ferrer R, Giralt M, Alegre-Martin J, Castro-Marrero J. Are Circulating Fibroblast Growth Factor 21 and N-Terminal Prohormone of Brain Natriuretic Peptide Promising Novel Biomarkers in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? Antioxid Redox Signal. 2021 Jun 20;34(18):1420-1427. doi: 10.1089/ars.2020.8230. Epub 2021 Feb 11.
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PubMed Identifier
33329554
Citation
Gomez-Mora E, Carrillo J, Urrea V, Rigau J, Alegre J, Cabrera C, Oltra E, Castro-Marrero J, Blanco J. Impact of Long-Term Cryopreservation on Blood Immune Cell Markers in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Implications for Biomarker Discovery. Front Immunol. 2020 Nov 17;11:582330. doi: 10.3389/fimmu.2020.582330. eCollection 2020.
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PubMed Identifier
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Citation
Giloteaux L, O'Neal A, Castro-Marrero J, Levine SM, Hanson MR. Cytokine profiling of extracellular vesicles isolated from plasma in myalgic encephalomyelitis/chronic fatigue syndrome: a pilot study. J Transl Med. 2020 Oct 12;18(1):387. doi: 10.1186/s12967-020-02560-0.
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Estevez-Lopez F, Mudie K, Wang-Steverding X, Bakken IJ, Ivanovs A, Castro-Marrero J, Nacul L, Alegre J, Zalewski P, Slomko J, Strand EB, Pheby D, Shikova E, Lorusso L, Capelli E, Sekulic S, Scheibenbogen C, Sepulveda N, Murovska M, Lacerda E. Systematic Review of the Epidemiological Burden of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Across Europe: Current Evidence and EUROMENE Research Recommendations for Epidemiology. J Clin Med. 2020 May 21;9(5):1557. doi: 10.3390/jcm9051557.
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Citation
Cheema AK, Sarria L, Bekheit M, Collado F, Almenar-Perez E, Martin-Martinez E, Alegre J, Castro-Marrero J, Fletcher MA, Klimas NG, Oltra E, Nathanson L. Unravelling myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): Gender-specific changes in the microRNA expression profiling in ME/CFS. J Cell Mol Med. 2020 May;24(10):5865-5877. doi: 10.1111/jcmm.15260. Epub 2020 Apr 14.
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Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
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