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Testing a dose calculation model for children with thyroid disease

Tests OptiThyDose for dosing in children with congenital hypothyroidism or Graves' disease.

Key facts

Who runs it
University Children's Hospital Basel
Where
Basel, Lausanne, Lucerne, Sankt Gallen, and Zurich, SwitzerlandSee the 5 sitesAlso in 2 other countries, 2 sites
Trial code
Registry title
Prospective Evaluation of OptiThyDose
Status
Recruiting
People taking part
150 people, planned
Started
28 Aug 2025
Expected to end
Feb 2029
Type of study
Interventional, 4 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • OptiThyDose
Record updated
2 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for newborns with congenital hypothyroidism (an underactive thyroid from birth) and children with Graves' disease (an overactive thyroid). It tests OptiThyDose, a math model that helps choose medicine doses.

Age
Up to 18 Years.
Sex
All sexes can join.
Disease stage
Congenital hypothyroidism: newborns with an abnormal newborn screening test, confirmed by a high TSH level in a separate vein blood sample. Graves' disease: a new diagnosis, a return of the disease, or disease not well controlled on CMZ/MMZ.
Earlier treatment
Children with Graves' disease can join if it is not well controlled under CMZ/MMZ treatment.
Biomarker or test result
Congenital hypothyroidism: increased Thyrotropin (TSH) level. Graves' disease: suppressed TSH, increased thyroid hormone levels and positive Anti-TSH-receptor antibodies.

Main reasons for not taking part

  • Newborns whose mothers have Graves' disease.
  • Patients who have a life-threatening event.
  • Other known causes of an overactive thyroid without raised Anti-TSH-receptor antibodies, such as toxic thyroid nodules.
  • Overactive thyroid caused by amiodarone or linked to McCune Albright syndrome.
  • Overactive thyroid caused by gene changes in the TSH receptor gene.

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Switzerland

Also in 2 other countries, 2 sites

  • Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB)Basel, SwitzerlandContact: Gabor Szinnai, Prof. MD, PhDTaking people
  • Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, SwitzerlandContact: Michael Hauschild, PD Dr.Taking people
  • Kinderspital Zentralschweiz (LUKS)Lucerne, SwitzerlandContact: Inge Ruiz Arana, Dr.Taking people
  • Ostschweizer Kinderspital (OKS)Sankt Gallen, SwitzerlandContact: Julia Rohayem, PD Dr.Taking people
  • Universitäts-Kinderspital Zürich - EleonorenstiftungZurich, SwitzerlandContact: Daniel Konrad, Prof. Dr.Taking people

About the trial

What the trial wants to find out

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).

The 4 groups in the trial

  • Control group w/ Congenital HypothyroidismNo study treatment, for comparison

    Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment

  • OptiThyDose w/ Congenital HypothyroidismTreatment being tested

    Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment

    Treatment: OptiThyDose

  • Control group w/ Graves' DiseaseNo study treatment, for comparison

    Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment

  • OptiThyDose w/ Graves' DiseaseTreatment being tested

    Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment

    Treatment: OptiThyDose

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective Evaluation of OptiThyDose, a Mathematical Model for Calculating Appropriate Dose Ranges in Children With Thyroid Diseases
Plain-language title
Testing a dose calculation model for children with thyroid diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
2 October 2026