Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/12/2005
Date assigned
08/08/2006
Last edited
28/04/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Pearce

ORCID ID

Contact details

School of Clinical Medical Sciences
University of Newcastle
Newcastle upon Tyne
NE2 4HH
United Kingdom
s.h.s.pearce@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0500783

Study information

Scientific title

Acronym

TRISH

Study hypothesis

Radioiodine treatment for sustained subclinical hyperthyroidism will not reduce circulatory endpoints in the elderly.

Ethics approval

Approval gained from the Newcastle and North Tyneside Research Ethics Committee (reference number: 06/Q0905/112).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Subclinical hyperthyroidism

Intervention

Radioiodine treatment versus usual care.

Intervention type

Drug

Phase

Not Specified

Drug names

Radioiodine

Primary outcome measures

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 trial start date

01/10/2006

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

780

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

30/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Clinical Medical Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

Research and Development Department
Clinical Research Facility
Leazes Wing
4th Floor
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes