NCT03887000

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

March 28, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

March 7, 2019

Last Update Submit

October 22, 2020

Conditions

Fibromyalgia

Keywords

FibromyalgiaStressMagnesiumSleep disorders

Outcome Measures

Primary Outcomes (1)

  • 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

    at day 0

Secondary Outcomes (27)

  • Evaluation of the impact of fibromyalgia using the FIQ questionnaire

    Day0; Day0+28; Day0+84

  • Detection of fibromyalgia using the FIRST questionnaire

    Day0; Day0+28; Day0+84

  • Evaluation of stress by the heart rate variability

    Day0-7; Day0; Day0+28; Day0+84

  • Assessment Using Numerical Scale (EN)

    Day0; Day0+28; Day0+84

  • Concise Pain Questionnaire (QCD)

    Day0; Day0+28; Day0+84

  • +22 more secondary outcomes

Study Arms (2)

MAGNESIUM

EXPERIMENTAL

Fibromyalgia patients taking either magnesium or placebo according to the randomized plan

Other: magnesiumOther: placebo

PLACEBO

EXPERIMENTAL

Fibromyalgia patients taking either magnesium or placebo according to the randomized plan

Other: magnesiumOther: placebo

Interventions

magnesiumOTHER

Fibromyalgia patients taking either magnesium or placebo according to the randomized plan

MAGNESIUMPLACEBO
placeboOTHER

Fibromyalgia patients taking either magnesium or placebo according to the randomized plan

MAGNESIUMPLACEBO

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • 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.

You may not qualify if:

  • 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,
  • 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 ....),
  • using anticoagulant therapy or allergy to local anesthetics,- of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

FibromyalgiaSleep Wake Disorders

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Gisèle PICKERING

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 22, 2019

Study Start

March 28, 2019

Primary Completion

January 12, 2020

Study Completion

May 12, 2020

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations

FR(1)