Magnesium, Stress and Fibromyalgia | NCT03887000

NCT03887000

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2018-A02059-46	Other Identifier	2018-A02059-46

Status Module

Name	Class
CIC Inserm 1405, University Hospital Clermont-Ferrand, France	UNKNOWN

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MAGNESIUM	Experimental	Fibromyalgia patients taking either magnesium or placebo according to the randomized plan	Other: magnesium Other: placebo
PLACEBO	Experimental	Fibromyalgia patients taking either magnesium or placebo according to the randomized plan	Other: magnesium Other: placebo

Name	Type	Description	Arm Group Labels	Other Names
magnesium	Other	Fibromyalgia patients taking either magnesium or placebo according to the randomized plan	MAGNESIUM PLACEBO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	Day0; Day0+28; Day0+84
Detection of fibromyalgia using the FIRST questionnaire

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 ....),
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.

ID	Term
D005356	Fibromyalgia
D012893	Sleep Wake Disorders