Patient-centered Dosage of Levothyroxine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Decision support tool.
- Who it may be relevant to
- Registry conditions: Hypothyroidism, Thyroid Cancer, Thyroid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient-centered Decision Support Tool for Levothyroxine Dosage
Overview
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.
Interventions
- Other Decision support tool
Patients in the intervention groups are given the option to use the decision support tool when adjusting the levothyroxine dose after total thyroidectomy. Levothyroxine therapy is not a part of the intervention, as all patients receive this therapy regardless of study participation.
Primary outcome measures
- Number of patients at biochemical target [Time frame: Outcome is measured at 8 weeks, 6 months and 12 months post surgery]
Secondary outcome measures (5)
- Time to biochemical target [Time frame: Measured at 18 months after surgery]
- Distance from biochemical target [Time frame: Measured at 8 weeks post surgery]
- Patient reported outcome - ThyPRO39 questionnaire [Time frame: Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery]
- Patient reported outcome - RAND-36 questionnaire [Time frame: Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery]
- Abscence from work [Time frame: Measured at18 months after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 3 centers
- Haukeland University Hospital — Bergen
- Oslo University Hospital — Oslo
- University Hospital of North Norway — Tromsø
Publications
- Brun 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
- Konst 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
Identifiers
NCT: NCT06455371 · 547311