CompletedPhase 4

LIthium as Bridging thErapy Prior to Radioactiveiodine in hyperThYroidism

Malaysia90 participantsStarted 2021-01-10

Plain-language summary

A prospective randomised controlled open label, single centre study. subjects will be randomised into lithium or carbimazole arms in a 1:1 ratio. Lithium arm will receive tab Lithium Carbonate 300mg daily while Carbimazole arm will receive tab Carbimazole 10mg daily for a duration of two months prior to radioactive iodine treatment. Changes in the thyroid hormone levels at 2 months of treatment and at months 1,3 and 6 following radioactive iodine will be evaluated.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Adult patients aged 18 years old and above with thyrotoxicosis who have been planned for definitive radioactive iodine: * consented for radioactive iodine as a definitive treatment * able to comply with requirement of radioactive iodine treatment * FT4 level below 40pmol/L Exclusion Criteria: * pregnancy or lactating mother * moderate to severe and active thyroid eye disease based on EUGOGO criteria, requires steroid cover * renal impairment, egfr \<45mls/min (stage 3b) * underlying activity malignancy * underlying active schizophrenia or bipolar disorder * patients on medication that may interact with lithium (refer appendix) * patients on medications that may interfere with radioactive iodine effectiveness such as amiodarone and less than a month of intravenous contrast medium * previous radioactive iodine less than 6 months * previous history of adverse effect following exposure to lithium or carbimazole * thyroid carcinoma

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

proportion of cure at 6months

Timeframe: 6 months

Trial details

NCT IDNCT05512715

SponsorUniversiti Kebangsaan Malaysia Medical Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-31

View on ClinicalTrials.gov More Hyperthyroidism/Thyrotoxicosis trials