Prospective Evaluation of OptiThyDose
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Children's Hospital Basel
- Trial code
- NCT06864351
- Record updated
- 2 October 2026
- Original description
The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).Read full original descriptionShow less
Prospective Evaluation of OptiThyDose, a Mathematical Model for Calculating Appropriate Dose Ranges in Children With Thyroid Diseases
The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).
Inclusion: Congenital hypothyroidism (CH); Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample; Graves' disease (GD); Children until 18 years with new diagnosis of GD, recurrence of GD, or insufficiently controlled GD under CMZ/MMZ during follow-up according to:; Pathological lab values (suppressed TSH, increased thyroid hormone levels, positive Anti-TSH-receptor antibodies); Typical clinical picture, if present (goitre, tachycardia, palpitations, weight loss, hyperphagia, altered mood); CH and GD; The study participant must be accessible for scheduled visits, treatment and follow-up; Signed Informed Consent form (ICF) obtained prior to any study related procedure. Written IC for study participation must be signed and dated by the patient and/or his/her legal representative(s) in accordance with national legal requirements.
Exclusion: Exclusion of children with known other aetiologies of hyperthyroidism than GD without elevated Anti-TSH-receptor antibodies e.g.:; known toxic thyroid nodules proven by ultrasound/scintigraphy; known amiodarone induced hyperthyroidism; known McCune Albright syndrome (based on clinical, laboratory, and genetic diagnosis) associated hyperthyroidism; known genetically proven hyperthyroidism caused by activating mutations of the TSH receptor gene; CH and GD; Exclusion of newborns from mothers with GD; Exclusion of patients in case of a life-threatening event; GD.