Clinical trial NCT01647750: Study of Optimal Replacement of Thyroxine in the Elderly
Official title: Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) SORTED 1 - a Randomised Controlled Trial (Pilot Study), SORTED 2 - Qualitative Interviews, SORTED 3 - Retrospective Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothyroidism
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2012-07-24
Enrollment: 48
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients with hypothyroidism are currently treated the same way, regardless of age. The investigators want to look at whether people aged 80 years or older would benefit from being treated with lower doses of levothyroxine. There are three reasons why the investigators think this could be beneficial, but this is not yet proven:

1. Some older people with hypothyroidism may have few symptoms.
2. Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patient's blood to decide the dose of Thyroxine received. The standard "normal" TSH range used to determine the dose of levothyroxine is from younger people. The investigators wonder whether this is appropriate to all age ranges particularly as the investigators know that older people may normally have higher TSH values.
3. If TSH levels are too low there may be a slight increased risk of problems such as brittle bones or an irregular heartbeat.

The best way to test whether older people benefit from lower doses of levothyroxine is by a large clinical trial. Before the investigators can do this, the investigators need to run a smaller clinical trial called a "pilot study" (SORTED 1) to examine whether this is practical and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism aged 80 or above.

Participants will be randomly allocated to receive their routine or lower dose of levothyroxine. Follow-up will be conducted over approximately 25 weeks.

The investigators also propose a qualitative study (SORTED 2) to specifically understand patient's willingness to take part in a RCT and participant's experience of the intervention.

Finally, the investigators propose a retrospective cohort study of 400 treated hypothyroid patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of studying outcomes after 4 years. The cohort study will collect data required to inform a sample size calculation for a future full study where the primary outcome will be 4 year mortality.


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)

Primary outcomes:
measure: Participant's acceptability of study design and willingness to enter study
timeFrame: Until completion of recruitment, approximately 24 months
Secondary outcomes:
measure: Participant recruitment rate
timeFrame: Until completion of recruitment, approximately 24 months
measure: Time to achieve desired TSH levels
timeFrame: Until participant completion of SORTED 1 study, approximately within 24 weeks
measure: Medication compliance
timeFrame: For the duration of participant involvment in the study, maximum of 25 weeks
measure: The acceptability of three patient completed questionnaires
timeFrame: For the duration of participant involvement in the study, maximum of 25 weeks
measure: Assessment of mobility
timeFrame: For the duration of participant involvement in this study, maximum of 25 weeks
measure: Change in specific cardiovascular risk factors
timeFrame: For the duration of participant involvement in the study, maximum of 25 weeks
measure: Measure of risk of falls
timeFrame: For the duration of participant involvement in the study, maximum 25 weeks
Other outcomes:
Locations:
city: Gateshead
country: United Kingdom
facility: Bensham Hospital
state: Tyne and Wear
city: Newcastle upon Tyne
country: United Kingdom
facility: Clinical Research Facility
state: Tyne and Wear
Study officials:
affiliation: Gateshead Health NHS Foundation Trust
name: Salman Razvi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Razvi S, Ingoe L, Ryan V, Pearce SH, Wilkes S. Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) - results from the feasibility randomised controlled trial. Thyroid Res. 2016 Oct 10;9:5. doi: 10.1186/s13044-016-0034-x. eCollection 2016.