Central Hypothyroidism, a Novel Laboratory Measurement

Central Hypothyroidism Clinical Trial

Official title:

Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01280292
• Other study ID #: SHEBA-10-8213-RP-CTIL
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 19, 2011
• Last updated: February 2, 2011
• Start date: February 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2011
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Central Hypothyroidism
• Hypothyroidism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	free T4 levels		a year	No
Secondary	Symptoms of hypothyroidism		a year	No