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Central Hypothyroidism, a Novel Laboratory Measurement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Sheba Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280292
First Posted: January 20, 2011
Last Update Posted: February 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
January 19, 2011
January 20, 2011
February 3, 2011
February 2011
February 2013   (Final data collection date for primary outcome measure)
free T4 levels [ Time Frame: a year ]
Same as current
Complete list of historical versions of study NCT01280292 on ClinicalTrials.gov Archive Site
Symptoms of hypothyroidism [ Time Frame: a year ]
Same as current
Not Provided
Not Provided
 
Central Hypothyroidism, a Novel Laboratory Measurement
Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Central Hypothyroidism
Drug: Eltroxin
Eltroxin dosage titration according to free T4 measurement every 3 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
July 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01280292
SHEBA-10-8213-RP-CTIL
No
Not Provided
Not Provided
Ruth Percik M.D., Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Ruth Percik, M.D. Sheba Medical Center
Sheba Medical Center
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP