Patient-Tailored Levothyroxine Dosage with Pharmacokinetic/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy.
Vegard Heimly Brun, Amund H Eriksen, Ruth Selseth...
https://pubmed.ncbi.nlm.nih.gov/33980057Actively Recruiting
Led by University Hospital of North Norway · Updated on 2025-09-10
240
Participants Needed
3
Research Sites
52 weeks
Total Duration
U
University Hospital of North Norway
Lead Sponsor
S
SINTEF Health Research
Collaborating Sponsor
Researchers are evaluating a decision support tool (DST) designed to help doctors adjust levothyroxine dosage more quickly for patients who have undergone total thyroidectomy. Levothyroxine is a common hormone replacement for people whose thyroid gland is no longer functioning properly. This randomized study compares the DST's early dosage recommendations with the usual practice of adjusting doses every two months, aiming to see if faster dose optimization improves patient outcomes and work ability. Participants will be randomly assigned to one of four groups: standard clinical practice where dosage is adjusted based on thyroid-stimulating hormone (TSH) levels every 6-8 weeks, or three experimental groups using different versions of the DST that calculate dosage changes based on blood samples taken within the first two weeks after surgery. The DST uses mathematical models with either 2 or 4 blood samples to recommend dosage adjustments. Throughout the study, patients will undergo blood tests to measure biochemical targets at 8 weeks, 6 months, 12 months, and up to 18 months after surgery. Patient-reported outcomes will be collected using the ThyPRO39 and RAND-36 questionnaires before surgery and at intervals afterward. Researchers will also monitor patients' time to reach the biochemical target, distance from target, and absence from work. The total participation duration includes follow-up assessments up to 18 months post-surgery.
CONDITIONS
Patient-centered Dosage of Levothyroxine
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months after surgery
Participants adjust their levothyroxine dose after total thyroidectomy using either standard clinical practice or one of three decision support tool models based on blood samples.
Visits every 6 to 8 weeks for dose adjustment and blood sampling
Duration - Up to 18 months after surgery
Participants are monitored for biochemical targets and patient-reported outcomes up to 18 months after surgery.
Assessments at 2 weeks before surgery, 8 weeks, 2 months, 6 months, 12 months, and 18 months after surgery
Total: 3 locations
1
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
2
Oslo University Hospital
Oslo, Norway
Actively Recruiting
3
University Hospital of North Norway
Tromsø, Norway, 9010
Actively Recruiting
V
Vegard Brun, PhD
S
Solveig Brun, cand.med
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Vegard Heimly Brun, Amund H Eriksen, Ruth Selseth...
https://pubmed.ncbi.nlm.nih.gov/33980057Solveig Robertsen Konst, Lars Hellemo, Beate Hennie Garcia...
https://pubmed.ncbi.nlm.nih.gov/41857858