Well being of patients with thyrotoxicosis after radioactive iodine treatment using block and replace compared to titrated regime
| ISRCTN | ISRCTN27681212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27681212 |
| Protocol serial number | N0203173366 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Royal Devon & Exeter NHS Foundation Trust (UK), NHS R&D Support Funding (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 08/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ponnusamy Saravanan
Scientific
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Radioactive iodine |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Well being of patients with thyrotoxicosis after radioactive iodine treatment using block and replace compared to titrated regime |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 13/09/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
