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HypothyroidismNCT06455371

Patient-centered Dosage of Levothyroxine

A study testing Decision support tool in people with Hypothyroidism and Thyroid Cancer, run by University Hospital of North Norway at 3 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypothyroidism, Thyroid Cancer, Thyroid
What is being tested?
Decision support tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
3 sitesNorway
Study dates
20 Dec 2024to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals

Who cannot join

  • Anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vegard Brun, PhD contact

0047 77669260

vegard.heimly.brun@unn.no

Solveig Brun, cand.med contact

004745253006

solveig.konst@unn.no

Norway3 sites, 3 recruiting

  • Haukeland University Hospital

    Bergen

    Renate Kollevåg Vik, PhD, +4795210732, Renate.Cecilie.Kollevag.Vik@helse-bergen.no

    Recruiting

  • Oslo University Hospital

    Oslo

    Ingrid Alm Andersen, PhD, +47 91 50 27 70, aningr@ous-hf.no

    Recruiting

  • University Hospital of North Norway

    Tromsø, 9010

    Solveig Konst, Cand.Med, +4777754259, solveig.konst@unn.no

    Recruiting

Other trials in Norway

About this study

Official title: Patient-centered Decision Support Tool for Levothyroxine Dosage

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.

Being tested
Decision support tool
Keywords
Decision support tool, Patient-centered dosage, thyroidectomy, levothyroxine
Medical subject headings
Hypothyroidism, Thyroid Neoplasms, Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decision support toolOther

    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.

Study groups in NCT06455371
Study groupRoleWhat they receive
ControlNo interventionCurrent 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
DST 1ExperimentalLevothyroxine dose is calculated using the current version of the decision support tool based on 4 blood samples.
Receives: Other: Decision support tool
DST 2ExperimentalLevothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 4 blood samples.
Receives: Other: Decision support tool
DST 3ExperimentalLevothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 2 blood samples.
Receives: Other: Decision support tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients at biochemical target

    Number of patients at biochemical target. Biochemical target is TSH (thyroid stimulating hormone) 0,5-2,0 mIE/L for patients on substitution therapy and 0,1-0,5 mIE/L for patients on suppression therapy

    Measured: Outcome is measured at 8 weeks, 6 months and 12 months post surgery

Secondary outcomes (5)

  1. Time to biochemical target

    Time to biochemical target is reached measured in days. Day 0 is day of surgery

    Measured: Measured at 18 months after surgery

  2. Distance from biochemical target

    Distance measured in TSH units.

    Measured: Measured at 8 weeks post surgery

  3. Patient reported outcome - ThyPRO39 questionnaire

    Patient reported outcomes measured by the validated questionnaire ThyPRO39. The ThyPRO39 questionnaire consist of 12 scales that covers physical symptoms (goiter, eye symptoms, hypo- and hyperthyroid symptoms), cosmetic appearance, physical, mental and social well-being and function. Each item is rated on a 0-4 scale from 0 = no symptoms/problems to 4 = Severe symptoms/problems. The average score of items in a scale is divided by four and multiplied by 100 to yield thirteen 0-100 scales, with higher scores indicating worse health status.

    The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups.

    Measured: Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery

  4. Patient reported outcome - RAND-36 questionnaire

    Rand-36 is the Norwegian translation of the SF-36 version 1.2. The questionnaire consists of 36 items, grouped into eight multi-item scales that measure physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. The scores can also be summarized into two summary scores for overall physical and mental health. Items scores will be transformed to 0-100 point scales (0=worst, 100=best) using the SF-36 scoring algorithm

    The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups.

    Measured: Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery

  5. Abscence from work

    Days with sick-leave from work the first year after surgery. Data collected from the Norwegian national sick-leave registry

    Measured: Measured at18 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start20 Dec 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455371
Sponsor's protocol ID
547311
Status last verified
Dec 2024
First submitted
10 Jan 2024
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 41857858

Questions about this trial

What is this clinical trial studying?

A study testing Decision support tool in people with Hypothyroidism and Thyroid Cancer, run by University Hospital of North Norway at 3 sites in Norway.

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 1 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vegard Brun, PhD (0047 77669260, vegard.heimly.brun@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients at biochemical target (time frame: Outcome is measured at 8 weeks, 6 months and 12 months post surgery). 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 NCT06455371, which also lists 2 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 10 Sep 2025.

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