Fatigue Syndrome, ChronicMELATOZINCNCT03000777
Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
A study testing melatonin plus zinc in people with Fatigue Syndrome, Chronic and Myalgic Encephalomyelitis, run by Laboratorios Viñas, S.A. at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fatigue Syndrome, Chronic, Myalgic Encephalomyelitis
- What is being tested?
- melatonin plus zinc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda definition.
- Patient who provided signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME
Read the 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.
- Being tested
- melatonin plus zinc, Placebo
- Keywords
- melatonin, zinc, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, sleep, pain
- Medical subject headings
- Fatigue Syndrome, Chronic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin plus zincDietary supplement
Also called MelatoZinc
Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks
PlaceboOther
Also called Control
Isomaltose o.d. 1 hour before going to bed during 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Melatonin plus Zinc | Experimental | Melatonin plus Zinc Receives: Dietary Supplement: melatonin plus zinc |
| Placebo | Placebo comparator | Isomaltose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration
Measured: within the first 16 weeks (plus 4 weeks with no treatment)
Secondary outcomes (5)
Side effects during treatment.
Measured: within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Measured: within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Measured: within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire.
Measured: within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire.
Measured: within the first 16 weeks (plus 4 weeks with no treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Viñas, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Vall d'Hebron, Laboratorio Echevarne
- Responsible party
- Sponsor
- Investigators
- José Alegre, MD; PhD, Principal investigator, Vall d'Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000777
- Sponsor's protocol ID
- IC/LV/MEL-ZN/SFC
- Acronym
- MELATOZINC
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23600892Castro-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.
PubMed 25386668Castro-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.
PubMed 26212172Saez-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.
PubMed 26343462Faro 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.
PubMed 26190206Calvo 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.
PubMed 25812543Faro 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.
PubMed 25433788Santamarina-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.
PubMed 24826505Saez-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.
PubMed 24630915Docampo 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.
PubMed 24582949Faro M, Saez-Francas N, Castro-Marrero J, Aliste L, Collado A, Alegre J. [Impact of the fibromyalgia in the chronic fatigue syndrome]. Med Clin (Barc). 2014 Jun 16;142(12):519-25. doi: 10.1016/j.medcli.2013.06.030. Epub 2014 Jan 2. Spanish.
PubMed 24387955Blazquez A, Ruiz E, Aliste L, Garcia-Quintana A, Alegre J. The effect of fatigue and fibromyalgia on sexual dysfunction in women with chronic fatigue syndrome. J Sex Marital Ther. 2015;41(1):1-10. doi: 10.1080/0092623X.2013.864370. Epub 2014 Mar 11.
PubMed 24274008Valero S, Saez-Francas N, Calvo N, Alegre J, Casas M. The role of neuroticism, perfectionism and depression in chronic fatigue syndrome. A structural equation modeling approach. Compr Psychiatry. 2013 Oct;54(7):1061-7. doi: 10.1016/j.comppsych.2013.04.015. Epub 2013 Jun 5.
PubMed 23759150Curriu M, Carrillo J, Massanella M, Rigau J, Alegre J, Puig J, Garcia-Quintana AM, Castro-Marrero J, Negredo E, Clotet B, Cabrera C, Blanco J. Screening NK-, B- and T-cell phenotype and function in patients suffering from Chronic Fatigue Syndrome. J Transl Med. 2013 Mar 20;11:68. doi: 10.1186/1479-5876-11-68.
PubMed 23514202Castro-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.
PubMed 34201806
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03000777
- Acronym / sponsor ID
- MELATOZINC / IC/LV/MEL-ZN/SFC
- Keywords
- melatonin, zinc, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, sleep, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laboratorios Viñas, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Vall d'Hebron, Laboratorio Echevarne
- Study start
- Feb 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin plus Zinc | Experimental | Dietary Supplement: melatonin plus zincMelatonin plus Zinc |
| Placebo | Placebo comparator | Other: PlaceboIsomaltose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda definition.
- Patient who provided signed informed consent.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatonin plus zincAlso: MelatoZincMelatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks | Dietary supplement | Melatonin plus Zinc |
| PlaceboAlso: ControlIsomaltose o.d. 1 hour before going to bed during 16 weeks | Other | Placebo |
Primary outcome
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)
5 secondary outcomes
Side effects during treatment.
Time frame: within the first 16 weeks (plus 4 weeks with no treatment)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 23600892Castro-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.
- Background: PubMed 25386668Castro-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.
- Background: PubMed 26212172Castro-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.
- Background: PubMed 26343462Saez-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.
- Background: PubMed 26190206Faro 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.
- Background: PubMed 25812543Calvo 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.
- Background: PubMed 25433788Faro 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.
- Background: PubMed 24826505Santamarina-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.
- Background: PubMed 24630915Saez-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.
- Background: PubMed 24582949Docampo 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.
- Background: PubMed 24387955Faro M, Saez-Francas N, Castro-Marrero J, Aliste L, Collado A, Alegre J. [Impact of the fibromyalgia in the chronic fatigue syndrome]. Med Clin (Barc). 2014 Jun 16;142(12):519-25. doi: 10.1016/j.medcli.2013.06.030. Epub 2014 Jan 2. Spanish.
- Background: PubMed 24274008Blazquez A, Ruiz E, Aliste L, Garcia-Quintana A, Alegre J. The effect of fatigue and fibromyalgia on sexual dysfunction in women with chronic fatigue syndrome. J Sex Marital Ther. 2015;41(1):1-10. doi: 10.1080/0092623X.2013.864370. Epub 2014 Mar 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Alegre, MD; PhD principal investigator
Vall d'Hebron University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin plus zinc in people with Fatigue Syndrome, Chronic and Myalgic Encephalomyelitis, run by Laboratorios Viñas, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000777, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.