Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05276856

Recovery Rate in Secondary Hypothyroidism

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levothyroxine

Drug

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).

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).

Primary outcomes

  1. Percentage of patients achieving euthyroid status

    Time frame: 12 weeks

    Percentage of patients able to maintain normal TSH/T4 without thyroxine replacment

Study contacts

Contact information is provided by the study sponsor or research team.

Hazem Aljumah

CONTACT

[email protected]

+17822340095

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.