Patient-centered Dosage of Levothyroxine

NCT06455371 | Recruiting DMC

• 1 other identifier: 547311
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief 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 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

Hypothyroidism; Thyroid Cancer; Thyroid

Keywords

Decision support tool; Patient-centered dosage; thyroidectomy; levothyroxine

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

• Time to biochemical target

  Measured at 18 months after surgery

• Distance from biochemical target

  Measured at 8 weeks post surgery

• Patient reported outcome - ThyPRO39 questionnaire

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

• Patient reported outcome - RAND-36 questionnaire

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

• Abscence from work

  Measured at18 months after surgery

Study Arms (4)

Control

NO INTERVENTION

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

DST 1

EXPERIMENTAL

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

Other: Decision support tool

DST 2

EXPERIMENTAL

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

Other: Decision support tool

DST 3

EXPERIMENTAL

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

Other: Decision support tool

Interventions

Decision support tool 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 1; DST 2; DST 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• SINTEF Health Research: collaborator
• Helseapps: collaborator
• Norinnova: collaborator
• Helse Nord: collaborator

Study Sites (3)

Haukeland University Hospital

Bergen, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

University Hospital of North Norway

Tromsø, 9010, Norway

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Hypothyroidism; Thyroid Neoplasms; Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Central Study Contacts

Vegard Brun, PhD

CONTACT

0047 77669260; vegard.heimly.brun@unn.no

Solveig Brun, cand.med

CONTACT

004745253006; solveig.konst@unn.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant physician and associate professor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: June 12, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)