Prospective Evaluation of OptiThyDose, a Mathematical Model for Calculating Appropriate Dose Ranges in Children With Thyroid Diseases

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

∙ 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

Locations
Other Locations
France
Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris
NOT_YET_RECRUITING
Paris
Switzerland
Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB)
RECRUITING
Basel
Contact Information
Primary
Gabor Szinnai, Prof. MD, PhD
Gabor.Szinnai@ukbb.ch
+41 61 704 29 22
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2029-02
Participants
Target number of participants: 150
Treatments
No_intervention: Control group w/ Congenital Hypothyroidism
Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment
Experimental: OptiThyDose w/ Congenital Hypothyroidism
Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment
No_intervention: Control group w/ Graves' Disease
Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment
Experimental: OptiThyDose w/ Graves' Disease
Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment
Sponsors
Leads: University Children's Hospital Basel

This content was sourced from clinicaltrials.gov