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Central Hypothyroidism, a Novel Laboratory Measurement

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01280292
First received: January 19, 2011
Last updated: February 2, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention
Central Hypothyroidism
 Drug: Eltroxin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • free T4 levels [ Time Frame: a year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of hypothyroidism [ Time Frame: a year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Eltroxin
    Eltroxin dosage titration according to free T4 measurement every 3 months
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280292

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

No publications provided

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
Study First Received: January 19, 2011
Last Updated: February 2, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013