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Central Hypothyroidism, a Novel Laboratory Measurement

Primary Purpose

Central Hypothyroidism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eltroxin
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Central Hypothyroidism focused on measuring central hypothyroidism, hypopituitarism, eltroxin

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    free T4 levels

    Secondary Outcome Measures

    Symptoms of hypothyroidism

    Full Information

    First Posted
    January 19, 2011
    Last Updated
    February 2, 2011
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01280292
    Brief Title
    Central Hypothyroidism, a Novel Laboratory Measurement
    Official Title
    Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    February 2013 (Anticipated)
    Study Completion Date
    July 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Hypothyroidism
    Keywords
    central hypothyroidism, hypopituitarism, eltroxin

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Eltroxin
    Intervention Description
    Eltroxin dosage titration according to free T4 measurement every 3 months
    Primary Outcome Measure Information:
    Title
    free T4 levels
    Time Frame
    a year
    Secondary Outcome Measure Information:
    Title
    Symptoms of hypothyroidism
    Time Frame
    a year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ruth Percik, M.D.
    Organizational Affiliation
    Sheba Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Central Hypothyroidism, a Novel Laboratory Measurement

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