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Central Hypothyroidism, a Novel Laboratory Measurement

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ClinicalTrials.gov Identifier: NCT01280292
Recruitment Status : Unknown
Verified February 2011 by Sheba Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : January 20, 2011
Last Update Posted : February 3, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Central Hypothyroidism Drug: Eltroxin

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement
Study Start Date : February 2011
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Eltroxin
    Eltroxin dosage titration according to free T4 measurement every 3 months

Outcome Measures

Primary Outcome Measures :
  1. free T4 levels [ Time Frame: a year ]

Secondary Outcome Measures :
  1. Symptoms of hypothyroidism [ Time Frame: a year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280292


Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ruth Percik, M.D. Sheba Medical Center
More Information

Responsible Party: Ruth Percik M.D., Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01280292     History of Changes
Other Study ID Numbers: SHEBA-10-8213-RP-CTIL
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: February 2011

Keywords provided by Sheba Medical Center:
central hypothyroidism, hypopituitarism, eltroxin

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases