Patient-centered Dosage of Levothyroxine

NCT ID: NCT06455371

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothyroidism Thyroid Cancer Thyroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

DST 1

Levothyroxine dose is calculated using the current version of the decision support tool based on 4 blood samples.

Group Type EXPERIMENTAL

Decision support tool

Intervention Type OTHER

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.

DST 2

Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 4 blood samples.

Group Type EXPERIMENTAL

Decision support tool

Intervention Type OTHER

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.

DST 3

Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 2 blood samples.

Group Type EXPERIMENTAL

Decision support tool

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SINTEF Health Research

OTHER

Sponsor Role collaborator

Helseapps

UNKNOWN

Sponsor Role collaborator

Norinnova

UNKNOWN

Sponsor Role collaborator

Helse Nord

INDUSTRY

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Vegard Brun

Consultant physician and associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

University Hospital of North Norway

Tromsø, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Vegard Brun, PhD

Role: CONTACT

0047 77669260

Solveig Brun, cand.med

Role: CONTACT

004745253006

Facility Contacts

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Renate Kollevåg Vik, PhD

Role: primary

+4795210732

Ingrid Alm Andersen, PhD

Role: primary

+47 91 50 27 70

Solveig Konst, Cand.Med

Role: primary

+4777754259

References

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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.

Reference Type BACKGROUND
PMID: 33980057 (View on PubMed)

Other Identifiers

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547311

Identifier Type: -

Identifier Source: org_study_id

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