Central Hypothyroidism, a Novel Laboratory Measurement
Primary Purpose
Central Hypothyroidism
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eltroxin
Sponsored by
About this trial
This is an interventional diagnostic trial for Central Hypothyroidism focused on measuring central hypothyroidism, hypopituitarism, eltroxin
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
Sites / Locations
Outcomes
Primary Outcome Measures
free T4 levels
Secondary Outcome Measures
Symptoms of hypothyroidism
Full Information
NCT ID
NCT01280292
First Posted
January 19, 2011
Last Updated
February 2, 2011
Sponsor
Sheba Medical Center
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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