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

Fatigue Syndrome, Chronic Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000777
• Other study ID #: IC/LV/MEL-ZN/SFC
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: August 2018
• Source: Laboratorios Viñas, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Myalgia
• Myalgic Encephalomyelitis
• Syndrome

Intervention

Dietary Supplement:
• melatonin plus zinc
Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks

Other:
• Placebo
Isomaltose o.d. 1 hour before going to bed during 16 weeks

Locations

Country	Name	City	State
Spain	Vall d'Hebron University Hospital	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Laboratorios Viñas, S.A.	Hospital Vall d'Hebron, Laboratorio Echevarne

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Blazquez A, Ruiz E, Aliste L, García-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. — View Citation

Calvo N, Sáez-Francàs 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. — View Citation

Castro-Marrero J, Cordero MD, Sáez-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. — View Citation

Castro-Marrero J, Cordero MD, Segundo MJ, Sáez-Francàs N, Calvo N, Román-Malo L, Aliste L, Fernández 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. — View Citation

Castro-Marrero J, Sáez-Francàs N, Segundo MJ, Calvo N, Faro M, Aliste L, Fernández 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. — View Citation

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. — View Citation

Docampo E, Escaramís G, Gratacòs 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):1102-9. doi: 10.1016/j.pain.2014.02.016. Epub 2014 Feb 26. — View 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. Spanish. — View Citation

Faro M, Sáez-Francàs 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. — View Citation

Faro M, Sàez-Francás N, Castro-Marrero J, Aliste L, Fernández 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. — View Citation

Sáez-Francàs N, Calvo N, Alegre J, Castro-Marrero J, Ramírez N, Hernández-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. — View Citation

Sáez-Francàs N, Valero S, Calvo N, Gomà-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. — View 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. — View Citation

Valero S, Sáez-Francàs 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects during treatment.		within the first 16 weeks (plus 4 weeks with no treatment)
Secondary	Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.		within the first 16 weeks (plus 4 weeks with no treatment)
Secondary	Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.		within the first 16 weeks (plus 4 weeks with no treatment)
Secondary	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)
Secondary	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)