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Melatonin and Immunonutrition for Pain Relief in Fibromyalgia
Sponsor: University of Thessaly
Summary
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.
Official title: Melatonin and Immunonutrition for Pain Relief in Fibromyalgia: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-10
Completion Date
2027-10
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Melatonin 1mg and intravenous B-complex vitamin drip
Patients will receive Melatonin 1mg half an hour before sleep every day and intravenous B-complex vitamin drip every week for a total of five weeks
Placebo
Per os corn startch placebo capsules every night half an hour before sleep and intravenous N/S 500mL drip every week
Locations (1)
Immunonutrition Unit, Department of Rheumatology and Clinical Immunology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece
Larissa, Greece