Antithyroid Drug Treatment of Thyrotoxicosis in Young People
Paediatric Thyrotoxicosis
About this trial
This is an interventional treatment trial for Paediatric Thyrotoxicosis focused on measuring thyrotoxic, thyrotoxicosis, paediatric, endocrinology, block and replace, dose titration, carbimazole
Eligibility Criteria
Inclusion Criteria:
- All patients with thyrotoxicosis aged between 2 and 16 years at the time of diagnosis. Thyrotoxicosis will be diagnosed by the paediatrician on the basis of the clinical picture and the biochemistry (suppressed TSH with high thyroid hormone levels).
- Child has consented/assented or consent via parent/guardian has been gained prior to any study specific procedures
Exclusion Criteria:
- Known toxic adenoma / toxic hyperplasia (germline activating TSHR mutation).
- McCune Albright Syndrome.
- Previous episodes of Thyrotoxicosis..
- Known allergic response to any of the study medication or ingredients as per SmPC.
- Previous participation in this study.
Sites / Locations
- Royal Aberdeen Children's Hospital
- Birmingham Children's Hospital
- Addebrookes Hospital
- Wales College of Medicine
- University Hospital
- Ninewells Hospital
- Royal Hospital for Sick Children
- Royal Hospital for Sick Children
- Hereford Hospital
- Crosshouse Hospital
- Alder Hey Children's Hospital
- St Bart's Hospital
- St George's Hospital
- Royal Manchester Children's Hospital
- Royal Victoria Infirmary
- Norfolk & Norwich University Hospitals
- Oxford Radcliffe Hospitals
- Sheffield Children's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Block and Replace
Dose Titration
Carbimazole is commenced in a dose of 0.75 mg/kg/day. The intention is to completely prevent endogenous thyroxine production. Thyroxine is then added in a replacement dose as the thyroid hormone levels fall into the lower half of the laboratory normal range. The principal measure of control during the first 6 months will be thyroid hormone levels rather than TSH.
Carbimazole is commenced in a dose of 0.75 mg/kg/day until thyroid hormone levels fall into the local laboratory normal range. The dose is then reduced to 0.25 mg/kg/day with the intention of maintaining the euthyroid state. The principal measure of control during the first 6 months will be thyroid hormone levels rather than TSH. Carbimazole is the preferred treatment because of the increased risk of hepatotoxicity with propylthiouracil but patients who are treated with propylthiouracil can also be recruited and randomised. 1mg of carbimazole is approximately equivalent to 10 mg of propylthiouracil. Drug: Carbimazole 5mg and 20 mg tablets. Administered as a once or twice daily regimen with total daily dose adjusted according to prevailing biochemistry Drug: propylthiouracil 50 mg tablets administered once daily with the dose adjusted according to the prevailing biochemistry.