To hear about similar clinical trials, please enter your email below
Trial Title:
Patient-centered Dosage of Levothyroxine
NCT ID:
NCT06455371
Condition:
Hypothyroidism
Thyroid Cancer
Thyroid
Conditions: Official terms:
Thyroid Diseases
Hypothyroidism
Conditions: Keywords:
Decision support tool
Patient-centered dosage
thyroidectomy
levothyroxine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Decision support tool
Description:
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.
Arm group label:
DST 1
Arm group label:
DST 2
Arm group label:
DST 3
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 2024
Completion date:
December 2027
Lead sponsor:
Agency:
University Hospital of North Norway
Agency class:
Other
Collaborator:
Agency:
SINTEF Health Research
Agency class:
Other
Collaborator:
Agency:
Helseapps
Agency class:
Other
Collaborator:
Agency:
Norinnova
Agency class:
Other
Collaborator:
Agency:
Helse Nord
Agency class:
Industry
Source:
University Hospital of North Norway
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06455371
