Patient-centered Dosage of Levothyroxine

University Hospital of North Norway

Status: Enrolling

Conditions: Hypothyroidism; Thyroid; Thyroid Cancer

Treatments: Other: Decision support tool

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06455371

547311

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

Control

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: Decision support tool

DST 2

Experimental group

Description:

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

Treatment:

Other: Decision support tool

DST 3

Experimental group

Description:

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

Treatment:

Other: Decision support tool