Central Hypothyroidism, a Novel Laboratory Measurement

NCT ID: NCT01280292

Last Updated: 2011-02-03

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-07-31

Brief Summary

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Medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based on T4 levels, measured with variable laboratory methods. Patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. This combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. Replacement therapy for central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th percentile of normal. The goal of our study is to compare the standard results from well known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem mass spectrometry.

Detailed Description

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Conditions

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Central Hypothyroidism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Eltroxin

Eltroxin dosage titration according to free T4 measurement every 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH

Exclusion Criteria

* Primary hypothyroidism
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Ruth Percik, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Other Identifiers

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SHEBA-10-8213-RP-CTIL

Identifier Type: -

Identifier Source: org_study_id

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