Improving lab diagnostics for patients with hypothyroidism using levothyroxine
Improvement of Laboratory Diagnostics in Hypothyroid Patients Using Levothyroxine
This study is trying to see if current lab tests accurately show thyroid hormone levels in people with hypothyroidism who are taking levothyroxine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06083636 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance laboratory diagnostics for hypothyroid patients undergoing treatment with levothyroxine (L-T4). It focuses on understanding the relationship between serum thyroid-stimulating hormone (TSH) and free T4 (fT4) levels in patients with various forms of hypothyroidism. Participants will undergo a single blood draw and complete a questionnaire to gather data on their thyroid hormone status and treatment efficacy. The study seeks to clarify whether current diagnostic measures accurately reflect thyroid hormone levels in patients receiving L-T4 therapy.
Who should consider this trial
Good fit: Ideal candidates include hypothyroid patients on a stable dosage of levothyroxine who are euthyroid based on TSH or fT4 levels according to their physician.
Not a fit: Patients who are not currently on levothyroxine or those whose thyroid hormone levels are not stable may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and treatment monitoring for hypothyroid patients, enhancing their overall health outcomes.
How similar studies have performed: While there have been studies on thyroid hormone monitoring, this specific approach to improving diagnostics in hypothyroid patients using levothyroxine is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, a hypothyroid subject must meet all of the following criteria: * Ability to provide informed consent * Ability to speak and understand Dutch or English * Intake of a stable dosage of levothyroxine, meaning the dosage of levothyroxine must not be changed during the appointment at the outpatient clinic * Diagnosis of one these forms of hypothyroidism * Patients with primary hypothyroidism: euthyroid based on TSH according to physician * Patients with hypothyroidism after a total thyroidectomy due to thyroid carcinoma (therefore athyroid): on target TSH according to physician (target TSH depending on stage/severity of carcinoma) * Patients using L-T4 due to therapy of Graves' disease: euthyroid based on TSH according to physician (TSH cannot be suppressed, namely TSH within reference interval of 0,5-5,0 mU/L) * Patients with central hypothyroidism: euthyroid based on fT4 according to physician (common is fT4 in the upper limit, reference interval is 12-22 pmol/L) In order to be eligible to participate in this study, a healthy control subject must meet all of the following criteria: * Ability to provide informed consent; * Ability to speak and understand Dutch or English * Consider themselves healthy Exclusion Criteria: A potential hypothyroid subject who meets any of the following criteria will be excluded from participation in this study: * Not euthyroid according to physician * Pregnancy * Patients using L-T4 due to therapy of Graves' disease: if TSH is still suppressed * Any of the following medication * Liothyronine (Cytomel) * Iodide * Oral contraceptives * Active treatment of malignancy (other than thyroid carcinoma) A potential healthy control subject who meets any of the following criteria will be excluded from participation in this study: * Pregnancy * Any of the following medication * Thyroid medication (a.o. levothyroxine, thiamazol, PTU) * Lithium * Amiodarone * Propranolol * Iodide * Glucocorticoids * Oral contraceptives * Heparin * Growth hormone * Active treatment of malignancy
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Annemieke C Heijboer, Prof. dr. — Amsterdam UMC, VU Amsterdam and UvA, Endocrine Laboratory, Department of Laboratory Medicine
- Study coordinator: Heijboer
- Email: a.heijboer@amsterdamumc.nl
- Phone: +31205665940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.