UK Trial of Radioiodine Intervention in Subclinical Hyperthyroidism
| ISRCTN | ISRCTN66874446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66874446 |
| Protocol serial number | G0500783 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Trust (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 16/12/2005
- Registration date
- 08/08/2006
- Last edited
- 13/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simon Pearce
Scientific
Scientific
School of Clinical Medical Sciences
University of Newcastle
Newcastle upon Tyne
NE2 4HH
United Kingdom
| s.h.s.pearce@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | UK Trial of Radioiodine Intervention in Subclinical Hyperthyroidism |
| Study acronym | TRISH |
| Study objectives | Radioiodine treatment for sustained subclinical hyperthyroidism will not reduce circulatory endpoints in the elderly. |
| Ethics approval(s) | Approval gained from the Newcastle and North Tyneside Research Ethics Committee (reference number: 06/Q0905/112). |
| Health condition(s) or problem(s) studied | Subclinical hyperthyroidism |
| Intervention | Radioiodine treatment versus usual care. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Radioiodine |
| Primary outcome measure(s) |
Composite circulatory mortality |
| Key secondary outcome measure(s) |
1. All cause mortality |
| Completion date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 780 |
| Key inclusion criteria | 1. Over 65 years of age 2. Sustained subclinical hyperthyroidism (undetectable Thyroid Stimulating Hormome [TSH], normal free thyroid hormones) for greater than three months |
| Key exclusion criteria | 1. Patient currently has or has ever had Atrial Fibrillation (AF) 2. Certain drug usage 3. Pituitary, severe renal or hepatic disease 4. Unstable coronary disease |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
School of Clinical Medical Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
Editorial Notes
13/11/2017: Internal review.
18/10/2017: Publication reference added.
