FibromyalgiaNCT07863232
Melatonin and Immunonutrition for Pain Relief in Fibromyalgia
A study testing Melatonin 1mg and intravenous B-complex vitamin drip in people with Fibromyalgia, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Melatonin 1mg and intravenous B-complex vitamin drip
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients diagnosed with Fibromyalgia Speak and understand the Greek language Consent to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Immunonutrition Unit, Department of Rheumatology and Clinical Immunology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece
Larissa, 41100
Arriana Gkouvi, MD, PhDc, 00302413502875, argkouvi@uth.gr
Maria G. Grammatikopoulou, As Professor, 00302413502813, mgrammat@uth.gr
About this study
Official title: 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.
Read the detailed description
Recent data have shown the potential role of melatonin as an adjuvant treatment in fibromyalgia (FMS), as it appears to improve sleep quality, reduce pain, and improve patient- and physician-reported assessments of quality of life. In addition to melatonin, intravenous micronutrient therapy has also been reported to improve symptoms in patients with fibromyalgia. More specifically, the intravenous administration of a mixture of vitamins and trace elements has been associated with reductions in pain, fatigue, and the number of tender points, as well as improvements in mood, quality of life, and energy levels for daily activities in patients with FM. Following a review of the available literature, a randomized, placebo-controlled clinical trial will be conducted to evaluate the efficacy of the combined administration of melatonin and intravenous vitamin drip in patients with FMS compared with a control group receiving placebo.
The primary outcomes will include changes in pain and quality of life, assessed using the following validated instruments: the Visual Analogue Scale (VAS), the Revised Fibromyalgia Impact Questionnaire (FIQR), the Functional Assessment of Chronic Illness Therapy (FACIT), and the Brief Pain Inventory (BPI). Additional primary outcome measures will include the patient's subjective perception of change, assessed using the Patient Global Impression of Change (PGIC), and the degree of central sensitization, assessed using the Central Sensitization Inventory (CSI).
The secondary outcomes will include changes in sleep-related symptoms, assessed using the Epworth Sleepiness Scale (ESS); changes in fatigue, assessed using the Fatigue Severity Scale (FSS); changes in psychological symptoms, assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); and changes in inflammatory markers, specifically C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
- Conditions
- Fibromyalgia
- Being tested
- Melatonin 1mg and intravenous B-complex vitamin drip, Placebo
- Keywords
- immunonutrition, FMS, melatonin, vitamins, pain, sleep, quality of life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 1mg and intravenous B-complex vitamin dripDietary supplement
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
PlaceboDietary supplement
Per os corn startch placebo capsules every night half an hour before sleep and intravenous N/S 500mL drip every week
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Per os Melatonin 1mg every night half an hour before sleep and intravenous B-complex vitamin drip every week Receives: Dietary Supplement: Melatonin 1mg and intravenous B-complex vitamin drip |
| Placebo | Placebo comparator | Per os corn startch placebo capsules every night half an hour before sleep and intravenous N/S 500mL drip every week Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain
Pain on a scale from 0 to 10 where 0 indicates "no pain" and 10 indicates "the worst possible pain"
Measured: 5 weeks
Brief Pain Inventory (BPI)
Measured: 5 weeks
Revised Fibromyalgia Impact Questionnaire (FIQR)
Measured: 5 weeks
Functional Assessment of Chronic Illness Therapy (FACIT)
Measured: 5 weeks
Patient Global Impression of Change (PGIC)
Measured: 5 weeks
Central Sensitization Inventory (CSI)
Measured: 5 weeks
Secondary outcomes (5)
Epworth Sleepiness Scale (ESS)
Measured: 5 weeks
Fatigue Severity Scale (FSS)
Measured: 5 weeks
Inflammatory markers
CRP, ESR
Measured: 5 weeks
Beck Depression Inventory (BDI)
Measured: 5 weeks
Beck anxiety inventory (BAI)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arriana Gkouvi, University of Thessaly
- Investigators
- Maria G. Grammatikopoulou, Assistant Professor, Principal investigator, Assistant Professor on Nutrition-Dietetics, at the Department of Medicine, University of Thessaly, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863232
- Sponsor's protocol ID
- 4/16th/08-11-22
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin and Immunonutrition for Pain Relief in Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07863232
- Acronym / sponsor ID
- 4/16th/08-11-22
- Conditions
- Fibromyalgia
- Keywords
- immunonutrition, FMS, melatonin, vitamins, pain, sleep, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recent data have shown the potential role of melatonin as an adjuvant treatment in fibromyalgia (FMS), as it appears to improve sleep quality, reduce pain, and improve patient- and physician-reported assessments of quality of life. In addition to melatonin, intravenous micronutrient therapy has also been reported to improve symptoms in patients with fibromyalgia. More specifically, the intravenous administration of a mixture of vitamins and trace elements has been associated with reductions in pain, fatigue, and the number of tender points, as well as improvements in mood, quality of life, and energy levels for daily activities in patients with FM. Following a review of the available literature, a randomized, placebo-controlled clinical trial will be conducted to evaluate the efficacy of the combined administration of melatonin and intravenous vitamin drip in patients with FMS compared with a control group receiving placebo.
The primary outcomes will include changes in pain and quality of life, assessed using the following validated instruments: the Visual Analogue Scale (VAS), the Revised Fibromyalgia Impact Questionnaire (FIQR), the Functional Assessment of Chronic Illness Therapy (FACIT), and the Brief Pain Inventory (BPI). Additional primary outcome measures will include the patient's subjective perception of change, assessed using the Patient Global Impression of Change (PGIC), and the degree of central sensitization, assessed using the Central Sensitization Inventory (CSI).
The secondary outcomes will include changes in sleep-related symptoms, assessed using the Epworth Sleepiness Scale (ESS); changes in fatigue, assessed using the Fatigue Severity Scale (FSS); changes in psychological symptoms, assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); and changes in inflammatory markers, specifically C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Dietary Supplement: Melatonin 1mg and intravenous B-complex vitamin dripPer os Melatonin 1mg every night half an hour before sleep and intravenous B-complex vitamin drip every week |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPer os corn startch placebo capsules every night half an hour before sleep and intravenous N/S 500mL drip every week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients diagnosed with Fibromyalgia Speak and understand the Greek language Consent to participate
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 1mg and intravenous B-complex vitamin dripPatients 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 | Dietary supplement | Immunonutrition |
| PlaceboPer os corn startch placebo capsules every night half an hour before sleep and intravenous N/S 500mL drip every week | Dietary supplement | Placebo |
Primary outcome
VAS pain
Time frame: 5 weeks
Pain on a scale from 0 to 10 where 0 indicates "no pain" and 10 indicates "the worst possible pain"
Brief Pain Inventory (BPI)
Time frame: 5 weeks
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: 5 weeks
Functional Assessment of Chronic Illness Therapy (FACIT)
Time frame: 5 weeks
Patient Global Impression of Change (PGIC)
Time frame: 5 weeks
Central Sensitization Inventory (CSI)
Time frame: 5 weeks
5 secondary outcomes
Epworth Sleepiness Scale (ESS)
Time frame: 5 weeks
Fatigue Severity Scale (FSS)
Time frame: 5 weeks
Inflammatory markers
Time frame: 5 weeks
Beck Depression Inventory (BDI)
Time frame: 5 weeks
Beck anxiety inventory (BAI)
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Fibromyalgia
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria G. Grammatikopoulou, Assistant Professor principal investigator
Assistant Professor on Nutrition-Dietetics, at the Department of Medicine, University of Thessaly, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 1mg and intravenous B-complex vitamin drip in people with Fibromyalgia, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arriana Gkouvi, MD, MSc, PhDc (00302413502875, argkouvi@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain (time frame: 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.