Recovery Rate in Secondary Hypothyroidism

Secondary Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05276856
• Other study ID #: RR in secondary hypothyroidism
• Status: Not yet recruiting
• Start date: March 10, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2022
• Source: Nova Scotia Health Authority
• Contact: Hazem Aljumah
• Phone: +17822340095
• Email: haaljumah1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 15, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism
• Neoplasm Metastasis
• Secondary Hypothyroidism

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

References & Publications (6)

Al-Dahmani K, Mohammad S, Imran F, Theriault C, Doucette S, Zwicker D, Yip CE, Clarke DB, Imran SA. Sellar Masses: An Epidemiological Study. Can J Neurol Sci. 2016 Mar;43(2):291-7. doi: 10.1017/cjn.2015.301. Epub 2015 Nov 2. — View Citation

Hudec M, Grigerova M, Walsh CH. Secondary hypothyroidism in hereditary hemochromatosis: recovery after iron depletion. Thyroid. 2008 Feb;18(2):255-7. doi: 10.1089/thy.2007.0140. — View Citation

Hwang JY, Aum DJ, Chicoine MR, Dacey RG Jr, Osbun JW, Rich KM, Zipfel GJ, Klatt-Cromwell CN, McJunkin JL, Pipkorn P, Schneider JS, Silverstein JM, Kim AH. Axis-specific analysis and predictors of endocrine recovery and deficits for non-functioning pituitary adenomas undergoing endoscopic transsphenoidal surgery. Pituitary. 2020 Aug;23(4):389-399. doi: 10.1007/s11102-020-01045-z. — View Citation

Livingston M, Birch K, Guy M, Kane J, Heald AH. No role for tri-iodothyronine (T3) testing in the assessment of levothyroxine (T4) over-replacement in hypothyroid patients. Br J Biomed Sci. 2015;72(4):160-3. — View Citation

Munro V, Tugwell B, Doucette S, Clarke DB, Lacroix A, Imran SA. Recovery of adrenal function after chronic secondary adrenal insufficiency in patients with hypopituitarism. Clin Endocrinol (Oxf). 2016 Aug;85(2):216-22. doi: 10.1111/cen.13048. Epub 2016 Mar 21. — View Citation

Zhang R, Wang Z, Gao L, Guo X, Feng C, Deng K, Lian W, Yao Y, Feng M, Bao X, Wang R, Xing B. Clinical Characteristics and Postoperative Recovery of Hypopituitarism in Patients with Nonfunctional Pituitary Adenoma. World Neurosurg. 2019 Jun;126:e1183-e1189. doi: 10.1016/j.wneu.2019.03.062. Epub 2019 Mar 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving euthyroid status	Percentage of patients able to maintain normal TSH/T4 without thyroxine replacment	12 weeks