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

NCT03000777 | Completed

• 1 other identifier: IC/LV/MEL-ZN/SFC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Fatigue Syndrome, Chronic; Myalgic Encephalomyelitis

Keywords

melatonin; zinc; Myalgic Encephalomyelitis; Chronic Fatigue Syndrome; sleep; pain

Outcome Measures

Primary Outcomes (1)

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

  within the first 16 weeks (plus 4 weeks with no treatment)

Secondary Outcomes (5)

• Side effects during treatment.

  within the first 16 weeks (plus 4 weeks with no treatment)

• Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.

  within the first 16 weeks (plus 4 weeks with no treatment)

• Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.

  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.

  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.

  within the first 16 weeks (plus 4 weeks with no treatment)

Study Arms (2)

Melatonin plus Zinc

EXPERIMENTAL

Melatonin plus Zinc

Dietary Supplement: melatonin plus zinc

Placebo

PLACEBO COMPARATOR

Isomaltose

Other: Placebo

Interventions

melatonin plus zinc DIETARY_SUPPLEMENT

Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks

Also known as: MelatoZinc

Melatonin plus Zinc

Placebo OTHER

Isomaltose o.d. 1 hour before going to bed during 16 weeks

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Viñas, S.A.: lead
• Hospital Vall d'Hebron: collaborator
• Laboratorio Echevarne: collaborator

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Related Publications (15)

• 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.

  PMID: 23600892 BACKGROUND

• 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.

  PMID: 25386668 BACKGROUND

• 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.

  PMID: 26212172 BACKGROUND

• 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.

  PMID: 26343462 BACKGROUND

• 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.

  PMID: 26190206 BACKGROUND

• 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.

  PMID: 25812543 BACKGROUND

• 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.

  PMID: 25433788 BACKGROUND

• 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.

  PMID: 24826505 BACKGROUND

• 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.

  PMID: 24630915 BACKGROUND

• 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.

  PMID: 24582949 BACKGROUND

• 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.

  PMID: 24387955 BACKGROUND

• 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.

  PMID: 24274008 BACKGROUND

• 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.

  PMID: 23759150 BACKGROUND

• 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.

  PMID: 23514202 BACKGROUND

• 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.

  PMID: 34201806 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Pain

Interventions

Melatonin; Zinc

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• José Alegre, MD; PhD

  Vall d'Hebron University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 22, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)