Health Trials

About this trial

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 criteria

Qualifiers

Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample

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)

The study participant must be accessible for scheduled visits, treatment and follow-up.

Disqualifiers

Exclusion of newborns from mothers with GD

Exclusion of patients in case of a life-threatening event

known toxic thyroid nodules proven by ultrasound/scintigraphy

known amiodarone induced hyperthyroidism

Trial design

Treatments tested in this trial

  • OptiThyDose

Treatment groups

150 Participants
are divided into 4 treatment groups

Locations

2
France
Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris75015, Paris France
Switzerland
Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB)4031, BaselCanton of Basel-City, Switzerland

Sponsors and collaborators

University Children's Hospital Basel

Lead sponsor

Source ClinicalTrials.gov