Recovery Rate in Secondary Hypothyroidism

August 19, 2024 updated by: Nova Scotia Health Authority

Rate of Recovery of Secondary Hypothyroidism in Patients With Pituitary Disorders.

The aim of this project is to assess the rate of recovery of secondary hypothyroidism in patients with pituitary disorders.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in three stages.

Stage 1 ( Patient identification and enrollment)

We will generate a list of all SHT patients from the HNP database and all patients will be contacted by the principal investigator (or their designate) regarding the study. Those patients who agree to participate in the study will be given a written consent form. We aim to enrol approximately 90 -100 patients for the study. Laboratory samples for serum TSH and T4 levels will be collected to confirm that all patients are adequately replaced for SHT. Those patients who are not adequately replaced and have low T4 will be excluded from the study.

Stage 2 (T4 withdrawal protocol)

Stepwise T4 replacement therapy will be initiated as follows.

Step 1:

  • Reduce the dose of T4 therapy by 50% and recheck serum T4 after 2 weeks.
  • If serum T4 is normal, go to step 2.
  • If serum T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).

The rationale for testing serum T4 after 2 weeks is that the half life of T4 is up to 7 days and early testing will potentially give false results. Furthermore, serum T3 is not a reliable test in patients taking T4 therapy and will not be requested 6.

Step 2:

  • Discontinue T4 therapy altogether and recheck serum TSH and T4 after 2 weeks.
  • If serum T4 is normal, go to step 3.
  • If serum T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).

Step 3:

  • Recheck serum TSH and T4 after 8 weeks.
  • If serum TSH and T4 levels are normal, these patients will be regarded as having successful T4 withdrawal.
  • If T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).

Stage 3 (Analysis)

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Halifax, Canada
        • Recruiting
        • Nova Scotia Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with pituitary disorders in the province of Nova Scotia are routinely enrolled in a computerized registry called the Halifax Neuropituitary (HNP) database. The database currently contains information on approximately 1800 patients. All pituitary hormonal dysfunctions are routinely identified in the HNP database. For this study, we will identify all patients with confirmed diagnosis of SHT who are currently taking T4 replacement therapy.

Description

Inclusion Criteria:

  • Confirmed diagnosis of secondary hypothyroidism who are currently taking T4 replacement therapy

Exclusion Criteria:

  • uncontrolled cardiovascular disease
  • uncontrolled congestive heart failure
  • uncontrolled mental health disorder
  • not adequately replaced and have low T4 level.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients achieving euthyroid status
Time Frame: 12 weeks
Percentage of patients able to maintain normal TSH/T4 without thyroxine replacment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RR in secondary hypothyroidism

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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