Clinical trial · Interventional
Patient-centered Dosage of Levothyroxine
Patient-centered Decision Support Tool for Levothyroxine Dosage
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypothyroidism | — | UNRESOLVED | — |
| Thyroid | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision support tool | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Control
- description
- Current clinical practise. Levothyroxine dose is calculated based on weight and adjusted according to TSH-level at 6-8 week intervals until biochemical target is reached
- type
- EXPERIMENTAL
- label
- DST 1
- description
- Levothyroxine dose is calculated using the current version of the decision support tool based on 4 blood samples.
- interventionNames
- Other: Decision support tool
- type
- EXPERIMENTAL
- label
- DST 2
- description
- Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 4 blood samples.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals Exclusion Criteria: * Anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy
References
Publications (2)
- BACKGROUNDBrun VH, Eriksen AH, Selseth R, Johansson K, Vik R, Davidsen B, Kaut M, Hellemo L. Patient-Tailored Levothyroxine Dosage with Pharmacokinetic/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy. Thyroid. 2021 Sep;31(9):1297-1304. doi: 10.1089/thy.2021.0125. Epub 2021 Jun 22. PMID 33980057
- DERIVEDKonst SR, Hellemo L, Garcia BH, Brun VH. Impact of a patient-centred levothyroxine decision support tool on rapid achievement of target dosage and improved patient outcomes: protocol for a randomised controlled trial. BMJ Open. 2026 Mar 18;16(3):e103512. doi: 10.1136/bmjopen-2025-103512. PMID 41857858