Study Results
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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RECRUITING
NA
240 participants
INTERVENTIONAL
2024-12-20
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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
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.
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.
DST 2
Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 4 blood samples.
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.
DST 3
Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 2 blood samples.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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SINTEF Health Research
OTHER
Helseapps
UNKNOWN
Norinnova
UNKNOWN
Helse Nord
INDUSTRY
University Hospital of North Norway
OTHER
Responsible Party
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Vegard Brun
Consultant physician and associate professor
Locations
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Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
University Hospital of North Norway
Tromsø, , Norway
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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547311
Identifier Type: -
Identifier Source: org_study_id
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