Central Hypothyroidism, a Novel Laboratory Measurement

NCT01280292 | Unknown

• 1 other identifier: SHEBA-10-8213-RP-CTIL
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Hypothyroidism

Keywords

central hypothyroidism, hypopituitarism, eltroxin

Outcome Measures

Primary Outcomes (1)

• free T4 levels

  a year

Secondary Outcomes (1)

• Symptoms of hypothyroidism

  a year

Interventions

Eltroxin DRUG

Eltroxin dosage titration according to free T4 measurement every 3 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Primary hypothyroidism

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Hypothyroidism; Hypopituitarism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ruth Percik, M.D.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 20, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 3, 2011

Record last verified: 2011-02