Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively 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 Ponnusamy Saravanan

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203173366

Study information

Scientific title

Well being of patients with thyrotoxicosis after radioactive iodine treatment using block and replace compared to titrated regime

Acronym

Study hypothesis

To assess whether the quality of life and well-being at 6 weeks, 6 months & 12 months using SF36-II and GHQ-12 (General Health Questionnaire) after radioactive iodine treatment for thyrotoxicosis is better with block & replacement regime compared to traditional titrating regime.

Ethics approval

Not provided at time of registration

Study design

Radioactive iodine

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Hyperthyroidism

Intervention

All the patients identified as suitable for radioactive iodine treatment will be referred to the endocrine specialist nurse as per the routine practice. The patients will then be screened for the inclusion and exclusion criteria. Eligible patients will then be sent / given written information about the study. Interested patients will come for their first visit to see the endocrine specialist nurse. After obtaining written informed consent, patients will be randomised to either the block & replace group or the titrated regime group. Six weeks after having the radioactive iodine treatment, patients will be seen by the endocrine specialist nurse for their second study visit. They will then follow the treatment algorithm. Third evaluation of patients is done at 6 months and the final evaluation is done at 12 months.

At each visit patient will be asked to fill up 3 questionnaires (SF36-II, GHQ-12 & TSQ). In addition they will fill up one question on satisfaction to treatment question. They will also have blood tests for their thyroid function. The blood test is part on the routine care and is not an additional test for the study.

User involvement: We will invite 1 or 2 thyrotoxicosis patients who has already under went radioactive iodine treatment to comment on the patient information sheets. We would also be giving regular feedback to the patients during and at the end of the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Differences in the scores on SF36-II & GHQ-12 between the 2 groups at 6 weeks, 6 months and 12 months, controlling for the baseline scores

Secondary outcome measures

Not provided at time of registration

Overall trial start date

13/09/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Toxic nodular thyroid disease (toxic multinodular goitre or toxic nodule)
2. Garves' thyrotoxicosis with patients' preference to have RAI
3. Recurrent Graves' thyrotoxicosis
4. Age between 18 and 80 years.

According to the current local practice, patients needing radioactive iodine treatment will be seen by our Endocrine Specialist Nurses. These patients will be assessed for their eligibility for this study. If the patients are eligible, they will be given the information sheet about the study. If they are happy to take part, before the radioactive iodine treatment, written consent will be obtained and patients will be randomised at that stage.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. Pregnant or lactating women
2. Patients allergic to antithyroid drugs or iodine
3. Active thyroid eye disease
4. Known alcohol or drug abuse
5. Significant psychiatric disturbances

Recruitment start date

13/09/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Devon & Exeter NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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