Study of Optimal Replacement of Thyroxine in the Elderly (SORTED)
Primary Purpose
Hypothyroidism
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Levothyroxine
Levothyroxine
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism
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)
Sites / Locations
- Bensham Hospital
- Clinical Research Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lower dose of levothyroxine
Standard dose of levothyroxine
Arm Description
Participants may be randomised to receive a lower dose of levothyroxine (lower than their usual dose) to achieve a target TSH level of 4.1 - 8.0 mU/L
Patients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L)
Outcomes
Primary Outcome Measures
Participant's acceptability of study design and willingness to enter study
Participant's acceptability of study design as measured byt he completion rate of participants in each randomised group, as well as their willingness to enter the trial (consented participant to eligible participant approached ratio)
Secondary Outcome Measures
Participant recruitment rate
As measured by the number of patients randomised divided by the length of the recruitment period. The recruitment period runs from the date that recruitment opened to the date of last randomisation.
Time to achieve desired TSH levels
To review and assess the dose titration strategy (ie reduced LT4 dose or same dose LT4) and length of time required to achieved desired TSH levels (ie number of participants in each group that reach target TSH range at both 12 and 24 weeks)
Medication compliance
Tablet count
The acceptability of three patient completed questionnaires
The questionnaires include the generic QoL questionnaire (EQ-5D), validated disease-specific QoL questionanaire (ThyDQol) and disease specific hypothyroid-symptom check list (ThySC). The time taken to complete the three questionnaires will be recorded and questionnaire completion rates will be recorded and usefulnesss of questionnaires determined. Any third-party held required in a questionnaire's completion will be recorded.
Assessment of mobility
Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)
Change in specific cardiovascular risk factors
Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results
Measure of risk of falls
Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.
Full Information
NCT ID
NCT01647750
First Posted
July 16, 2012
Last Updated
October 7, 2015
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT01647750
Brief Title
Study of Optimal Replacement of Thyroxine in the Elderly
Acronym
SORTED
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Some older people with hypothyroidism may have few symptoms.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lower dose of levothyroxine
Arm Type
Other
Arm Description
Participants may be randomised to receive a lower dose of levothyroxine (lower than their usual dose) to achieve a target TSH level of 4.1 - 8.0 mU/L
Arm Title
Standard dose of levothyroxine
Arm Type
Other
Arm Description
Patients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L)
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Intervention Description
Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Intervention Description
Participants in the standard dose of treatment will receive their usual dose of levothyroxine
Primary Outcome Measure Information:
Title
Participant's acceptability of study design and willingness to enter study
Description
Participant's acceptability of study design as measured byt he completion rate of participants in each randomised group, as well as their willingness to enter the trial (consented participant to eligible participant approached ratio)
Time Frame
Until completion of recruitment, approximately 24 months
Secondary Outcome Measure Information:
Title
Participant recruitment rate
Description
As measured by the number of patients randomised divided by the length of the recruitment period. The recruitment period runs from the date that recruitment opened to the date of last randomisation.
Time Frame
Until completion of recruitment, approximately 24 months
Title
Time to achieve desired TSH levels
Description
To review and assess the dose titration strategy (ie reduced LT4 dose or same dose LT4) and length of time required to achieved desired TSH levels (ie number of participants in each group that reach target TSH range at both 12 and 24 weeks)
Time Frame
Until participant completion of SORTED 1 study, approximately within 24 weeks
Title
Medication compliance
Description
Tablet count
Time Frame
For the duration of participant involvment in the study, maximum of 25 weeks
Title
The acceptability of three patient completed questionnaires
Description
The questionnaires include the generic QoL questionnaire (EQ-5D), validated disease-specific QoL questionanaire (ThyDQol) and disease specific hypothyroid-symptom check list (ThySC). The time taken to complete the three questionnaires will be recorded and questionnaire completion rates will be recorded and usefulnesss of questionnaires determined. Any third-party held required in a questionnaire's completion will be recorded.
Time Frame
For the duration of participant involvement in the study, maximum of 25 weeks
Title
Assessment of mobility
Description
Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)
Time Frame
For the duration of participant involvement in this study, maximum of 25 weeks
Title
Change in specific cardiovascular risk factors
Description
Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results
Time Frame
For the duration of participant involvement in the study, maximum of 25 weeks
Title
Measure of risk of falls
Description
Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.
Time Frame
For the duration of participant involvement in the study, maximum 25 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salman Razvi
Organizational Affiliation
Gateshead Health NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bensham Hospital
City
Gateshead
State/Province
Tyne and Wear
ZIP/Postal Code
NE8 4YL
Country
United Kingdom
Facility Name
Clinical Research Facility
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27766119
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.
Results Reference
derived
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Study of Optimal Replacement of Thyroxine in the Elderly
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