Recovery Rate in Secondary Hypothyroidism

NCT05276856 | Recruiting

• 1 other identifier: RR in secondary hypothyroidism
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving euthyroid status

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

  12 weeks

Interventions

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).

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health

Halifax, Canada

RECRUITING

Related 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.

  PMID: 26522017 BACKGROUND

• 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.

  PMID: 26928716 BACKGROUND

• 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.

  PMID: 18205549 BACKGROUND

• 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.

  PMID: 32388803 BACKGROUND

• 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.

  PMID: 30880207 BACKGROUND

• 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. doi: 10.1080/09674845.2015.11665746.

  PMID: 26738396 BACKGROUND

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine 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

Central Study Contacts

Hazem Aljumah

CONTACT

+17822340095; haaljumah1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 11, 2022
• Study Start: April 4, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)