FibromyalgiaSeMAForNCT03887000
Magnesium, Stress and Fibromyalgia
A study testing magnesium in people with Fibromyalgia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Fibromyalgia affects an average of 2% of the French population. Data from the literature report that low levels of magnesium could be associated with fibromyalgia. However, no study to date has investigated the effect of oral magnesium administration on stress in fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- magnesium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2019to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over the age of 18,
- Patient with fibromyalgia according to the criteria of the 2016 ACR,
- Patient presenting a score on the DASS-42 > 18 scale,
- Patient free from any initiation of new treatment or diet at the time of inclusion,
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Acceptance to give written consent,
- Affiliation to the French Social Security system,
- Registration or acceptance of registration in the National Register of Volunteers participating in research.
Who cannot join
- having a contraindication to the administration of magnesium: hypersensitivity to magnesium chloride, or to any of the excipients,
- with a magnesium concentration of > 1.05 mmol / l,- with severe renal impairment with a creatinine clearance < 30 ml / min,
- receiving a treatment or dietary supplement containing magnesium at the time of inclusion,
- treated with antibiotics in the three months prior to inclusion,- who has reported gastroenteritis in the two months prior to inclusion,
- physically unfit to place the palms or soles of the feet on the Sudoscan® electrodes,
- having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test (in particular a disease known to cause small fiber neuropathies: diabetes, Sjögren's disease, vasculitis, sarcoidosis, chronic ethylism ....),
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- using anticoagulant therapy or allergy to local anesthetics,- of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman.
- participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 4500 over the 12 months preceding the start of the trial,
- having cooperation and understanding that does not allow strict compliance with the conditions laid down in the Protocol,
- benefiting from a measure of legal protection (guardianship, guardianship, deprivation of liberty, safeguard of justice),
- not affiliated to the French Social Security system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Magnesium on Stress in Fibromyalgia: Randomized Double-blind Placebo Controlled Trial
Fibromyalgia affects an average of 2% of the French population. Data from the literature report that low levels of magnesium could be associated with fibromyalgia. However, no study to date has investigated the effect of oral magnesium administration on stress in fibromyalgia.
This trial therefore aims to evaluate whether magnesium could improve stress and the various disorders that contribute to the complexity of fibromyalgia, including pain, cognition, sleep disorders and quality of life.
Read the detailed description
This is an interventional, randomized, placebo-controlled, double blind study of the use of magnesium in fibromyalgia. The effect of magnesium on stress measured by DASS-42 over 28 days after taking magnesium / placebo will be studied.
The secondary objectives will evaluate the evolution of the scores of all the tests and questionnaires carried out before taking magnesium or placebo (D0: Visit 2), then at D0 + 28 (visit 3) and D0 + 84 days (visit 4 corresponding to the end-of-study visit).
Secondary parameters are the following :
Impact of fibromyalgia, heart rate variability, pain intensity, cognition, feelings of patients, impression of change, sleep quality, fatigue intensity, social vulnerability, catastrophism, presence of small fiber neuropathy, stress induced by colors, pain induced by thermal stimulation, concentration of magnesium, analysis of microbiota and evaluation of genetic factor.
Blood magnesium and magnesuria will be measured.
- Conditions
- Fibromyalgia
- Being tested
- magnesium, placebo
- Keywords
- Fibromyalgia, Stress, Magnesium, Sleep disorders
- Medical subject headings
- Fibromyalgia, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesiumOther
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
placeboOther
Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
| Study group | Role | What they receive |
|---|---|---|
| MAGNESIUM | Experimental | Fibromyalgia patients taking either magnesium or placebo according to the randomized plan Receives: Other: magnesium; Other: placebo |
| PLACEBO | Experimental | Fibromyalgia patients taking either magnesium or placebo according to the randomized plan Receives: Other: magnesium; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of stress with DASS-42
Measure of stress with stress subscale in magnesium and placebo group. This subscale consists of 14 questions of self-evaluation
Measured: at day 0
Secondary outcomes (27)
Evaluation of the impact of fibromyalgia using the FIQ questionnaire
The revised FIQ questionnaire is a 10-item self-questionnaire that assesses the impact of fibromyalgia
Measured: Day0; Day0+28; Day0+84
Detection of fibromyalgia using the FIRST questionnaire
The FIRST questionnaire is a 6-item self-questionnaire that detects fibromyalgia.
Measured: Day0; Day0+28; Day0+84
Evaluation of stress by the heart rate variability
Heart rate variability (HRV / HRV) is a measure of changes in heart rate that will provide an estimate of stress. It is usually calculated by analyzing time series of beat-by-beat intervals of the ECG or blood pressure plots.
Measured: Day0-7; Day0; Day0+28; Day0+84
Assessment Using Numerical Scale (EN)
This scale allows the patient to note the pain on a graduation whose minimum score is 0 and the maximum score is 10.
Measured: Day0; Day0+28; Day0+84
Concise Pain Questionnaire (QCD)
This self-assessment scale allows the patient to characterize the pain in relation to its psychosocial intensity and impact. The patient is asked to answer 9 graduated questions by circling a number from 0 (no pain) to 10 (the most horrible pain you can imagine).
Measured: Day0; Day0+28; Day0+84
Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B) and the Cantab® test
The Trail Making Test (TMT) is recognized as one of the most frequently used neuropsychological tests in clinical practice alternating numbers and letters (1-A-2-B-3- C, etc.).
The Cantab® is a comprehension test, executive functions, memory, attention and decision-making.
Measured: Day0; Day0+28; Day0+84
Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B)
The Trail Making Test (TMT) is recognized as one of the most frequently used neuropsychological tests in clinical practice alternating numbers and letters (1-A-2-B-3- C, etc.).
Measured: Day0; Day0+28; Day0+84
Cantab® test
The Cantab® is a comprehension test, executive functions, memory, attention and decision-making.
Measured: Day0; Day0+28; Day0+84
Evaluation of the emotions by visualization of images and scale evaluating the feelings of the patients
The International Affective Picture System (IAPS) is a library of 1200 standardized images that can induce an emotional reaction, constituting as many emotional stimuli (positive or negative) or not (neutral).
Measured: Day0; Day0+28; Day0+84
Evaluation of the overall impression of change by the Patient Global Impression of Change Questionnaire (PGIC)
The Global Impression of Change Patient is a scale of global perception of change ("deterioration" or "improvement") completed by the patient. This scale is graduated from 1 = much better to 7 = significantly worse
Measured: Day0; Day0+28; Day0+84
Evaluation of the impact on the Pittsburg Sleep Quality Index (PSQI)
The Pittsburg Sleep Quality Index is a self-administered questionnaire with 19 items. It has been developed to measure the quality of sleep in the month preceding the interview with the patient. This questionnaire has 7 components: subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of a sleep medication, and poor daytime fitness
Measured: Day0; Day0+28; Day0+84
Evaluation of the intensity of fatigue by the Fatigue Severity Scale (FSS)
The fatigue severity scale is a 9-item self-questionnaire to assess the patient's fatigue intensity. The patient is asked to circle a number from 1 to 7 for each question, a low value representing a low intensity
Measured: Day0; Day0+28; Day0+84
Social Vulnerability Assessment (EPICES)
The EPICES questionnaire is composed of 11 binary questions (yes / no) allowing to calculate an individual score indicating the precariousness and inequalities of health ranging from 0 to 100.
Measured: Day0; Day0+28; Day0+84
Evaluation of catastrophism by the PCS (Pain Catastrophizing Scale) scale
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Measured: Day0; Day0+28; Day0+84
Quality of life (Short Form 12 items Short Form survey)
assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12)
Measured: Day0; Day0+28; Day0+84
Evaluation of the presence of small fiber neuropathy (Sudoscan® )
Sudoscan® (Impeto Medical, Paris, France) is a new device that provides a rapid, non-invasive and reproducible quantitative assessment of sweat function.
Measured: AT Day0; Day0+28
Evaluation of the presence of small fiber neuropathy (skin biopsy)
A skin biopsy will be realized for histological analysis to determine the presence of small fiber neuropathy.
Measured: at Day0
plasma magnesium dosage
The intracellular magnesium concentrations will be determined by the blood samples taken at the inclusion visit, at the end of the treatment on visit 3 (D0 + 28) and on visit 4 (D0 + 84).
Measured: D0; D0+28; D0+84
erythrocyte magnesium dosage
The erythrocyte magnesium concentrations will be determined by the blood samples taken at the inclusion visit, at the end of the treatment on visit 3 (D0 + 28) and on visit 4 (D0 + 84).
Measured: D0; D0+28; D0+84
urinary magnesium dosage
The urinary concentration of magnesium will be determined by the urine collected for 24 hours, the day before visits 3 and 4.
Measured: D0; D0+28; D0+84
urinary magnesium dosage
The urinary concentration of magnesium will be determined by the urine collected for 24 hours, the day before visits 3 and 4.
Measured: D0+28; D0+84
creatinine dosage
The creatinine concentrations will be determined by the blood samples taken at the inclusion visit.
Measured: D0-7
Analysis of the microbiota (stool samples)
Analysis of the microbiota: the patient must carry out the collection at her home maximum 24 hours before the visit 2 by following the technical instructions described in the explanatory note that will be provided. She will then ensure that the stool preservation and transport procedure described in this document is followed.
Measured: 24 hours before the visit 2
Evaluation of genetic polymorphism using OpenArray technology
Identification of genes involved
Measured: Day0-7
Evaluation of stress response during visual stimulation
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" following different visual stimulation induced by different colors during the anticipatory phase of pain.
Measured: Day0; Day0+28
Evaluation of pain response during thermal stimulation
Pain intensity will be assessed by the numerical pain rating scale (NPRS): the scale ranges from 0 "no pain" to 10 "maximal tolerable pain" following different thermal stimulations (using Pathway Medoc®).
Measured: Day0; Day0+28
Evaluation of electromyography (EMG) of median nerve
EMG motor and sensitive of the median nerve on both arm to control the speed of electrical conduction. For this purpose, we will measure the amplitude, latency and speed for the motor test, and the amplitude and speed for the sensitivity test.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start28 Mar 2019
- Primary completion12 Jan 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- CIC Inserm 1405, University Hospital Clermont-Ferrand, France
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887000
- Sponsor's protocol ID
- CHU-429
- Other IDs
- 2018-A02059-46
- Acronym
- SeMAFor
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2019
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Macian N, Duale C, Voute M, Leray V, Courrent M, Bode P, Giron F, Sonneville S, Bernard L, Joanny F, Menard K, Ducheix G, Pereira B, Pickering G. Short-Term Magnesium Therapy Alleviates Moderate Stress in Patients with Fibromyalgia: A Randomized Double-Blind Clinical Trial. Nutrients. 2022 May 17;14(10):2088. doi: 10.3390/nu14102088.
PubMed 35631229
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium on Stress in Fibromyalgia: Randomized Double-blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03887000
- Acronym / sponsor ID
- SeMAFor / CHU-429
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Stress, Magnesium, Sleep disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- CIC Inserm 1405, University Hospital Clermont-Ferrand, France
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 22 Mar 2019 (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 affects an average of 2% of the French population. Data from the literature report that low levels of magnesium could be associated with fibromyalgia. However, no study to date has investigated the effect of oral magnesium administration on stress in fibromyalgia.
This trial therefore aims to evaluate whether magnesium could improve stress and the various disorders that contribute to the complexity of fibromyalgia, including pain, cognition, sleep disorders and quality of life.
Detailed description
This is an interventional, randomized, placebo-controlled, double blind study of the use of magnesium in fibromyalgia. The effect of magnesium on stress measured by DASS-42 over 28 days after taking magnesium / placebo will be studied.
The secondary objectives will evaluate the evolution of the scores of all the tests and questionnaires carried out before taking magnesium or placebo (D0: Visit 2), then at D0 + 28 (visit 3) and D0 + 84 days (visit 4 corresponding to the end-of-study visit).
Secondary parameters are the following :
Impact of fibromyalgia, heart rate variability, pain intensity, cognition, feelings of patients, impression of change, sleep quality, fatigue intensity, social vulnerability, catastrophism, presence of small fiber neuropathy, stress induced by colors, pain induced by thermal stimulation, concentration of magnesium, analysis of microbiota and evaluation of genetic factor.
Blood magnesium and magnesuria will be measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAGNESIUM | Experimental | Other: magnesium, Other: placeboFibromyalgia patients taking either magnesium or placebo according to the randomized plan |
| PLACEBO | Experimental | Other: magnesium, Other: placeboFibromyalgia patients taking either magnesium or placebo according to the randomized plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient over the age of 18,
- Patient with fibromyalgia according to the criteria of the 2016 ACR,
- Patient presenting a score on the DASS-42 > 18 scale,
- Patient free from any initiation of new treatment or diet at the time of inclusion,
- Cooperation and understanding sufficient to comply with the requirements of the study,
Key exclusion criteria (11 listed)
- having a contraindication to the administration of magnesium: hypersensitivity to magnesium chloride, or to any of the excipients,
- with a magnesium concentration of > 1.05 mmol / l,- with severe renal impairment with a creatinine clearance < 30 ml / min,
- receiving a treatment or dietary supplement containing magnesium at the time of inclusion,
- treated with antibiotics in the three months prior to inclusion,- who has reported gastroenteritis in the two months prior to inclusion,
- physically unfit to place the palms or soles of the feet on the Sudoscan® electrodes,
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 |
|---|---|---|
| magnesiumFibromyalgia patients taking either magnesium or placebo according to the randomized plan | Other | MAGNESIUM, PLACEBO |
| placeboFibromyalgia patients taking either magnesium or placebo according to the randomized plan | Other | MAGNESIUM, PLACEBO |
Primary outcome
Measure of stress with DASS-42
Time frame: at day 0
Measure of stress with stress subscale in magnesium and placebo group. This subscale consists of 14 questions of self-evaluation
27 secondary outcomes
Evaluation of the impact of fibromyalgia using the FIQ questionnaire
Time frame: Day0; Day0+28; Day0+84
Detection of fibromyalgia using the FIRST questionnaire
Time frame: Day0; Day0+28; Day0+84
Evaluation of stress by the heart rate variability
Time frame: Day0-7; Day0; Day0+28; Day0+84
Assessment Using Numerical Scale (EN)
Time frame: Day0; Day0+28; Day0+84
Concise Pain Questionnaire (QCD)
Time frame: Day0; Day0+28; Day0+84
Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B) and the Cantab® test
Time frame: Day0; Day0+28; Day0+84
Evaluation of the impact on cognition by the Trail Making Test A and B (TMT A and B)
Time frame: Day0; Day0+28; Day0+84
Cantab® test
Time frame: Day0; Day0+28; Day0+84
Evaluation of the emotions by visualization of images and scale evaluating the feelings of the patients
Time frame: Day0; Day0+28; Day0+84
Evaluation of the overall impression of change by the Patient Global Impression of Change Questionnaire (PGIC)
Time frame: Day0; Day0+28; Day0+84
Evaluation of the impact on the Pittsburg Sleep Quality Index (PSQI)
Time frame: Day0; Day0+28; Day0+84
Evaluation of the intensity of fatigue by the Fatigue Severity Scale (FSS)
Time frame: Day0; Day0+28; Day0+84
Social Vulnerability Assessment (EPICES)
Time frame: Day0; Day0+28; Day0+84
Evaluation of catastrophism by the PCS (Pain Catastrophizing Scale) scale
Time frame: Day0; Day0+28; Day0+84
Quality of life (Short Form 12 items Short Form survey)
Time frame: Day0; Day0+28; Day0+84
Evaluation of the presence of small fiber neuropathy (Sudoscan® )
Time frame: AT Day0; Day0+28
Evaluation of the presence of small fiber neuropathy (skin biopsy)
Time frame: at Day0
plasma magnesium dosage
Time frame: D0; D0+28; D0+84
erythrocyte magnesium dosage
Time frame: D0; D0+28; D0+84
urinary magnesium dosage
Time frame: D0; D0+28; D0+84
urinary magnesium dosage
Time frame: D0+28; D0+84
creatinine dosage
Time frame: D0-7
Analysis of the microbiota (stool samples)
Time frame: 24 hours before the visit 2
Evaluation of genetic polymorphism using OpenArray technology
Time frame: Day0-7
Evaluation of stress response during visual stimulation
Time frame: Day0; Day0+28
Evaluation of pain response during thermal stimulation
Time frame: Day0; Day0+28
Evaluation of electromyography (EMG) of median nerve
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 35631229Macian N, Duale C, Voute M, Leray V, Courrent M, Bode P, Giron F, Sonneville S, Bernard L, Joanny F, Menard K, Ducheix G, Pereira B, Pickering G. Short-Term Magnesium Therapy Alleviates Moderate Stress in Patients with Fibromyalgia: A Randomized Double-Blind Clinical Trial. Nutrients. 2022 May 17;14(10):2088. doi: 10.3390/nu14102088.
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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. This study is not recruiting at the moment.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnesium in people with Fibromyalgia, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 5 Aug 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of stress with DASS-42 (time frame: at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887000, which also lists 1 linked publication.
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 5 Aug 2026.