Prospective Evaluation of OptiThyDose

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 28, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

February 28, 2029

Conditions
Thyroid DiseasesCongenital HypothyroidismGraves Disease
Interventions
OTHER

OptiThyDose

"OptiThyDose is an iterative mathematical model applied at each patient visit, consisting of three components: (i) a disease-specific pharmacometrics (PMX) model, (ii) an empirical Bayesian estimation (EBE) component, and (iii) an optimal control theory (OCT) component. It calculates the optimal LT4 or CMZ/MMZ dose to maintain Free Thyroxine (FT4) levels within the upper half of the age-specific reference range, integrating past clinical and lab data.~Dosing follows international guidelines, with physicians able to consult OptiThyDose for individualized dosing within recommended ranges. At each outpatient visit, the physician can either (A) prescribe a dose within OptiThyDose's suggested range or (B) choose a dose based on personal experience."

Trial Locations (2)

4031

RECRUITING

Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB), Basel

75015

NOT_YET_RECRUITING

Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris

All Listed Sponsors
lead

University Children's Hospital Basel

OTHER