Patient-centered Dosage of Levothyroxine

Sponsor
University Hospital of North Norway
Study ID
NCT06455371
Status
Recruiting
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Conditions

  • Hypothyroidism
  • Thyroid
  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 12, 2024
Start date
Dec 20, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: 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
  • Experimental: DST 1
    Levothyroxine dose is calculated using the current version of the decision support tool based on 4 blood samples.
  • Experimental: DST 2
    Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 4 blood samples.
  • Experimental: DST 3
    Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 2 blood samples.

Primary Outcome Measure

Number of patients at biochemical target [ Time Frame: Outcome is measured at 8 weeks, 6 months and 12 months post surgery ]

Central Contacts

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