HypothyroidismPhase 4SORTEDNCT01647750
Study of Optimal Replacement of Thyroxine in the Elderly
A Phase 4 study testing Levothyroxine in people with Hypothyroidism, run by Newcastle-upon-Tyne Hospitals NHS Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Levothyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Bensham Hospital
Gateshead, Tyne and Wear, NE8 4YL
Clinical Research Facility
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
About this study
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
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.
Read more
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.
- Conditions
- Hypothyroidism
- Being tested
- Levothyroxine
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
LevothyroxineDrug
Participants in the standard dose of treatment will receive their usual dose of levothyroxine
| Study group | Role | What they receive |
|---|---|---|
| Lower dose of levothyroxine | Other | 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 Receives: Drug: Levothyroxine |
| Standard dose of levothyroxine | Other | Patients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L) Receives: Drug: Levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Until completion of recruitment, approximately 24 months
Secondary outcomes (7)
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.
Measured: Until completion of recruitment, approximately 24 months
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)
Measured: Until participant completion of SORTED 1 study, approximately within 24 weeks
Medication compliance
Tablet count
Measured: For the duration of participant involvment in the study, maximum of 25 weeks
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.
Measured: For the duration of participant involvement in the study, maximum of 25 weeks
Assessment of mobility
Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)
Measured: For the duration of participant involvement in this study, maximum of 25 weeks
Change in specific cardiovascular risk factors
Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results
Measured: For the duration of participant involvement in the study, maximum of 25 weeks
Measure of risk of falls
Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.
Measured: For the duration of participant involvement in the study, maximum 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Salman Razvi, Principal investigator, Gateshead Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647750
- Sponsor's protocol ID
- 5863
- Other IDs
- PB-PG-0610-22139, 2011-004425-27, ISRCTN16043724
- Acronym
- SORTED
- Status last verified
- Oct 2015
- First submitted
- 16 Jul 2012
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27766119
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01647750
- Acronym / sponsor ID
- SORTED / 5863
- Conditions
- Hypothyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower dose of levothyroxine | Other | Drug: LevothyroxineParticipants 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 |
| Standard dose of levothyroxine | Other | Drug: LevothyroxinePatients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L) |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineParticipants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose | Drug | Lower dose of levothyroxine |
| LevothyroxineParticipants in the standard dose of treatment will receive their usual dose of levothyroxine | Drug | Standard dose of levothyroxine |
Primary outcome
Participant's acceptability of study design and willingness to enter study
Time frame: Until completion of recruitment, approximately 24 months
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)
7 secondary outcomes
Participant recruitment rate
Time frame: Until completion of recruitment, approximately 24 months
Time to achieve desired TSH levels
Time frame: Until participant completion of SORTED 1 study, approximately within 24 weeks
Medication compliance
Time frame: For the duration of participant involvment in the study, maximum of 25 weeks
The acceptability of three patient completed questionnaires
Time frame: For the duration of participant involvement in the study, maximum of 25 weeks
Assessment of mobility
Time frame: For the duration of participant involvement in this study, maximum of 25 weeks
Change in specific cardiovascular risk factors
Time frame: For the duration of participant involvement in the study, maximum of 25 weeks
Measure of risk of falls
Time frame: For the duration of participant involvement in the study, maximum 25 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 27766119Razvi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salman Razvi principal investigator
Gateshead Health NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine in people with Hypothyroidism, run by Newcastle-upon-Tyne Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant's acceptability of study design and willingness to enter study (time frame: Until completion of recruitment, approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.