Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
NCT ID: NCT03000777
Last Updated: 2018-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-02-29
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Melatonin plus Zinc
Melatonin plus Zinc
melatonin plus zinc
Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks
Placebo
Isomaltose
Placebo
Isomaltose o.d. 1 hour before going to bed during 16 weeks
Interventions
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melatonin plus zinc
Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks
Placebo
Isomaltose o.d. 1 hour before going to bed during 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient who provided signed informed consent.
Exclusion Criteria
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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Hospital Vall d'Hebron
OTHER
Laboratorio Echevarne
INDUSTRY
Laboratorios Viñas, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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José Alegre, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron University Hospital
Locations
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Vall d'Hebron University Hospital
Barcelona, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Faro 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.
Blazquez 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.
Valero 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.
Curriu 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.
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.
Other Identifiers
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IC/LV/MEL-ZN/SFC
Identifier Type: -
Identifier Source: org_study_id
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