Secondary HypothyroidismNCT05276856
Recovery Rate in Secondary Hypothyroidism
An observational study of Secondary Hypothyroidism, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The aim of this project is to assess the rate of recovery of secondary hypothyroidism in patients with pituitary disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hypothyroidism
- What is being tested?
- Levothyroxine
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Confirmed diagnosis of secondary hypothyroidism who are currently taking T4 replacement therapy
Who cannot join
- uncontrolled cardiovascular disease
- uncontrolled congestive heart failure
- uncontrolled mental health disorder
- not adequately replaced and have low T4 level.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health
Halifax
Syed Ali Imran, MD, (902) 473-4997, ali.imran@nshealth.ca
About this study
Official title: 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.
Read the 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)
- Conditions
- Secondary Hypothyroidism
- Being tested
- Levothyroxine
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving euthyroid status
Percentage of patients able to maintain normal TSH/T4 without thyroxine replacment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start4 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Secondary HypothyroidismStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276856
- Sponsor's protocol ID
- RR in secondary hypothyroidism
- Status last verified
- Aug 2024
- First submitted
- 28 Feb 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26522017Munro 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.
PubMed 26928716Hudec 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.
PubMed 18205549Hwang 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.
PubMed 32388803Zhang 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.
PubMed 30880207Livingston 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.
PubMed 26738396
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Recovery of Secondary Hypothyroidism in Patients With Pituitary Disorders.
- ClinicalTrials.gov ID
- NCT05276856
- Acronym / sponsor ID
- RR in secondary hypothyroidism
- Conditions
- Secondary Hypothyroidism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to assess the rate of recovery of secondary hypothyroidism in patients with pituitary disorders.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Confirmed diagnosis of secondary hypothyroidism who are currently taking T4 replacement therapy
Key exclusion criteria (4 listed)
- uncontrolled cardiovascular disease
- uncontrolled congestive heart failure
- uncontrolled mental health disorder
- not adequately replaced and have low T4 level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineStep 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). | Drug | – |
Primary outcome
Percentage of patients achieving euthyroid status
Time frame: 12 weeks
Percentage of patients able to maintain normal TSH/T4 without thyroxine replacment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 26522017Al-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.
- Background: PubMed 26928716Munro 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.
- Background: PubMed 18205549Hudec 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.
- Background: PubMed 32388803Hwang 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.
- Background: PubMed 30880207Zhang 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.
- Background: PubMed 26738396Livingston 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.
Related trials for Secondary Hypothyroidism
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
RecruitingObservational study
Improvement of Laboratory Diagnostics in Hypothyroid Patients Using Levothyroxine
Hypothyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Hypothyroidism, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazem Aljumah (+17822340095, haaljumah1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving euthyroid status (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276856, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.