UK Trial of Radioiodine Intervention in Subclinical Hyperthyroidism
| ISRCTN | ISRCTN66874446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66874446 |
| Secondary identifying numbers | G0500783 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Radioiodine |
| Primary outcome measure | Composite circulatory mortality |
| Secondary outcome measures | 1. All cause mortality 2. Atrial fibrillation 3. Progression to overt hyperthyroidism 4. Hip and vertebral fractures 5. MMTS |
| Overall study start date | 01/10/2006 |
| Completion date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
School of Clinical Medical Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Clinical Research Facility
Leazes Wing, 4th Floor
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
