Determination of Baseline Thyroid Status Values in French Adult Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-01-31

Brief Summary

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The objective of this study is to establish reference values in the general population from a Beckman Coulter DxI chemiluminescence assay.

Indeed, the lack of harmonization of the methods of the dosage remains a major difficulty to optimize the management of patients with thyroid disease.

This supplier has recently optimized its dosing kit according to the 3rd international standard of the WHO (IRB 81/565) for the TSH (Thyroid Stimulating Hormon).

It is necessary to carry out a study of the distribution of the values of this TSH within our metropolitan population. The current data proposed by the supplier come from a study of a North American population.

investigators propose to define usual values for thyroid status markers (TSH, FT4 \[free thyroxine\], FT3 \[free triiodothyroxine\]) from healthy EFS (French Blood Establishment) donors who meet the standard exclusion criteria for this type of study.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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dosages in Healthy volunteers

Only one arm : healthy volunteer blood donors. Performing a blood test for the determination of parameters that explore thyroid status : only once.

Absence of other healthy volunteers group all healthy volunteers have a blood test performed in the same way.

Group Type OTHER

Dosages of Thyroid parameters

Intervention Type OTHER

Dosages of the following parameters: TSH, FT4 FT3, TGAb (Tyroglobulin antibody) , TPO Ab (ThyroPeroxydase Antibody)

Interventions

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Dosages of Thyroid parameters

Dosages of the following parameters: TSH, FT4 FT3, TGAb (Tyroglobulin antibody) , TPO Ab (ThyroPeroxydase Antibody)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Donors (18-70 years old) volunteers at EFS

Exclusion Criteria

* pregnancy,
* known antecedents of thyroid diseases (goiter, nodule, hypo or hyperthyroidism),
* current antithyroid treatment (neomercazole \[Thyrozol(r)\], levothyroxyn LT4 \[levothyrox(r)\], ...),
* cardiac treatment with amiodarone (cordarone(r)),
* injection of iodinated contrast medium less than 1 month old

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes