LIthium as Bridging thErapy Prior to Radioactiveiodine in hyperThYroidism

NCT05512715 | Completed Phase 4

• 1 other identifier: JEP-2020-763
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperthyroidism/Thyrotoxicosis

Outcome Measures

Primary Outcomes (1)

• proportion of cure at 6months

  to assess the proportion of cure at 6 months of radioactive iodine between those who were pre-treated with lithium vs carbimazole

  6 months

Secondary Outcomes (1)

• change in serum thyroid hormone

  2 months

Study Arms (2)

Lithium

ACTIVE COMPARATOR

Tablet Lithium Carbonate 300mg daily for 2 months

Procedure: radioactive iodine

Carbimazole

ACTIVE COMPARATOR

Tablet Carbimazole 10mg daily for 2 months

Procedure: radioactive iodine

Interventions

radioactive iodine PROCEDURE

radioactive iodine 15mci

Carbimazole; Lithium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Hyperthyroidism; Thyrotoxicosis

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Norlela Sukor

  Hospital Canselor Tuanku Muhriz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised into lithium or carbimazole arms in a 1:1 ratio

Study Record Dates

• First Submitted: August 20, 2022
• First Posted: August 23, 2022
• Study Start: January 10, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 23, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)