Melatonin and Immunonutrition for Pain Relief in Fibromyalgia
Key facts
- Where
- Larissa, GreeceSee the site
Where in Greece
- Immunonutrition Unit, Department of Rheumatology and Clinical Immunology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, GreeceLarissa, GreeceContact: Arriana Gkouvi, MD, PhDcTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Thessaly
- Trial code
- NCT07863232
- Record updated
- 7 October 2026
- Original description
Fibromyalgia (FMS) is characterized by chronic musculoskeletal pain, sleep disturbances, and fatigue. It is not entirely clear how Bcomplex vitamins affect the human pain system, while at the same time there have been approaches that use melatonin in patients with FMS and report improvements in pain and sleep quality.Read full original descriptionShow less
Melatonin and Immunonutrition for Pain Relief in Fibromyalgia: a Randomized Controlled Trial
Fibromyalgia (FMS) is characterized by chronic musculoskeletal pain, sleep disturbances, and fatigue. It is not entirely clear how Bcomplex vitamins affect the human pain system, while at the same time there have been approaches that use melatonin in patients with FMS and report improvements in pain and sleep quality.
The purpose of this study is to investigate the efficacy of a combined immunonutrition and melatonin intervention in patients with FMS through a randomized clinical trial (RCT). The combined effect of immunonutrition and melatonin, administered intravenously once a week and orally respectively, versus placebo, will be examined in patients with FMS, for a period of 5 weeks. The primary endpoints concern the quantification of pain and quality of life, while the secondary endpoints are sleep quality, fatigue and inflammatory markers.
Inclusion: Adult patients diagnosed with Fibromyalgia Speak and understand the Greek language Consent to participate.
Exclusion: Children and adolescents Diagnosed with other chronic pain disorders or autoimmune disease Recent modification of their treatment (within 3 months) Pregnant and breastfeeding women Patients with severe renal or cardiac disease, cancer, infection, epilepsy.