Recruiting

Observational Study

Sponsor:

Nova Scotia Health Authority

Code:

NCT05276856

Conditions

Secondary Hypothyroidism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Levothyroxine

Study Details

Brief summary:

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

Conditions

Secondary Hypothyroidism

Study ID

NCT05276856

Start date

Apr 4, 2022

Status verified date

Aug, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Interventions

Levothyroxine

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 outcome measure

  • Percentage of patients achieving euthyroid status [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Hazem Aljumah

+17822340095haaljumah1@gmail.com

Locations

Nova Scotia Health

Recruiting

Halifax, Canada

Contacts

Syed Ali Imran, MD

(902) 473-4997ali.imran@nshealth.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-21.