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Magnesium, Stress and Fibromyalgia — SeMAFor  

Fibromyalgia Clinical Trial

Official title:
Effect of Magnesium on Stress in Fibromyalgia: Randomized Double-blind Placebo Controlled Trial

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03887000
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact
Status Completed
Phase N/A
Start date March 28, 2019
Completion date May 12, 2020
View Details
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