Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT01647750
Eligibility Criteria:
Inclusion Criteria:
* Males and Females aged 80 years or older
* Diagnosed with hypothyroidism and treated with Levothyroxine for at least 6 months
* Living independently in the community
* All TSH results within the range 0.4 - 4mU/L in the 3 months before commencing the study
* Participant has provided written informed consent for participation in the study, prior to any study-specific procedures
Exclusion Criteria:
* Established dementia and therefore deemed incapable of providing informed consent.
* Other medical conditions which, inthe opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound)
* Nursing Homes or Residential Care Home residents
* Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH
* Individuals on 25 mcg dailty of LT4: dose reduction will mean that they stop thyroid replacement treatment
* Non english speaking individuals
* Participation in any other investigational trials within the last 3 months
* Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil)
* Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
80 Years
Study:
NCT01647750
Study Brief:
Protocol Section:
NCT01647750