81
Participants
Start Date
July 31, 2004
Primary Completion Date
December 31, 2014
Study Completion Date
November 30, 2015
Block and Replace
The primary objective of treatment is to maintain a euthyroid state with TSH and thyroid hormone levels in the local laboratory normal range. Carbimazole is commenced in a dose of 0.75 mg/kg/day (propylthiouracil - for dose see below) with the aim being to completely preventing endogenous thyroxine production. Thyroxine is then added in a low replacement dose as the thyroid hormone levels fall into the lower half of the laboratory normal range. The principle 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.
Dose Titration
"The primary objective of treatment is to maintain a euthyroid state with TSH and thyroid hormone levels in the local laboratory normal range.~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 a euthyroid state as reflected by a free thyroxine and TSH within the normal range.~Most paediatricians in the UK commence thyrotoxic children on carbimazole rather than propylthiouracil. 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. The guidelines detailed above can be used in the knowledge that 1mg of carbimazole is approximately equivalent to 10 mg of propylthiouracil."
carbimazole
Carbimazole 5mg and 20 mg tablets Administered as a once or twice daily regimen with total daily dose adjusted according to prevailing biochemistry
propylthiouracil
50 mg tablets administered once daily with the dose adjusted according to the prevailing biochemistry
thyroxine
25mcg, 50mcg and 100mcg tabletes administered once daily with the dose adjusted according to the prevailing biochemistry
Royal Aberdeen Children's Hospital, Aberdeen
Birmingham Children's Hospital, Birmingham
Addebrookes Hospital, Cambridge
Wales College of Medicine, Cardiff
University Hospital, Coventry
Ninewells Hospital, Dundee
Royal Hospital for Sick Children, Edinburgh
Royal Hospital for Sick Children, Glasgow
Hereford Hospital, Hereford
Crosshouse Hospital, Kilmarnock
Alder Hey Children's Hospital, Liverpool
St Bart's Hospital, London
St George's Hospital, London
Royal Manchester Children's Hospital, Manchester
Royal Victoria Infirmary, Newcastle upon Tyne
Norfolk & Norwich University Hospitals, Norwich
Oxford Radcliffe Hospitals, Oxford
Sheffield Children's Hospital, Sheffield
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER