Determination of Baseline Thyroid Status Values in French Adult Population

Not Applicable

• Conditions: Healthy
• Interventions: Other: Dosages of Thyroid parameters

• Registration Number: NCT03748407
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-30
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-19
• Last Update Submitted: 2018-11-19
• Study First Posted: 2018-11-20
• Last Update Posted: 2018-11-20
• Study Start: 2018-11-30
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dosages in Healthy volunteers	Dosages of Thyroid parameters	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.

Primary Outcome Measures

Name	Time	Method
Determination of the usual values of FT3	baseline	Determination of the usual values of FT3 after assays on DxI automaton of the Beckman Company according to the standardization 3rd international standard (IRB 81/565)
Determination of the usual values of FT4	baseline	Determination of the usual values of FT4 after assays on DxI automaton of the Beckman Company according to the standardization 3rd international standard (IRB 81/565)
Determination of the usual values of TSH	baseline	Determination of the usual values of TSH after assays on DxI automaton of the Beckman Company according to the standardization 3rd international standard (IRB 81/565)