Exploration of the Transfer of Barium From Thermal Mud

Last updated: July 8, 2020
Sponsor: Association Francaise pour la Recherche Thermale
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04111653
2019-A01614-53
  • Ages 18-30
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

It involves conducting a clinical study on a population of healthy volunteers (age between 18 and 30 years) without direct benefit for the subject to explore a transfer of barium in the blood and urine following applications of thermal mud. The main objective is to highlight an increase in serum barium level of at least twice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • volunteers, healthy (without known and / or treated disease)

  • 18 to 30 years old,

  • men and women, who can give their informed consent, presenting the elements ofcutaneous and general tolerance of sludge applications

  • patient affiliated to a social security scheme

Exclusion

Exclusion Criteria:

  • subject who can not give informed consent

  • pregnant woman ; woman of childbearing years not wishing to have contraceptionavailable for the duration of the trial

  • subject to a legal protection measure or a judicial review, subject having a knownallergy to a heavy metal, a BMI greater than 30

  • a characterized contact eczema, an active dermatosis, an acute affection, a disorderof the cutaneous sensitivity, an intolerance to the heat

  • heart, kidney or lung disease that may be decompensated with the use of hot products

  • a progressive disease (inflammatory, infectious or tumoral) potentially liable toworsen with the application of thermal physical agents

Study Design

Total Participants: 36
Study Start date:
January 13, 2020
Estimated Completion Date:
September 30, 2020

Study Description

The presence of barium in thermal clays was noted by the ARS (french administration) who interviewed the Directorate General of Health (DGS); the latter seized the National Academy of Medicine (June 2016) which reported in February 2017.

In this report it was stated that there was no argument in favor of toxic phenomena related to the presence of barium but that it was appropriate, in particular, to evaluate a possible passage of barium in the skin in subjects who are treated with thermal mud

  • by observing, where appropriate, an increase in serum and urinary barium levels in the subjects concerned and

  • by measuring a possible depletion of barium in the sludge used. The DGS validated the various recommendations of the Academy and asked, in January 2018, the National Council of Thermal Establishments (CNETH) to implement the recommendations of the Academy.

It will therefore be a prospective before-after interventional study, implementing 15 daily applications of 6 mud poultices made with a clay used as thermal clay and containing appreciable barium levels.

A surveillance will be put in place with the event of suspected event, the volunteer can then be seen by a doctor.

Connect with a study center

  • Institut du Thermalisme

    Dax, 40100
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.