Study of Optimal Replacement of Thyroxine in the Elderly (SORTED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Dr Salman Razvi, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01647750
First received: July 16, 2012
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hypothyroidism
Drug: Levothyroxine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Participant's acceptability of study design and willingness to enter study [ Time Frame: Until completion of recruitment, approximately 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Until completion of recruitment, approximately 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Until participant completion of SORTED 1 study, approximately within 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: For the duration of participant involvment in the study, maximum of 25 weeks ] [ Designated as safety issue: No ]
    Tablet count

  • The acceptability of three patient completed questionnaires [ Time Frame: For the duration of participant involvement in the study, maximum of 25 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: For the duration of participant involvement in this study, maximum of 25 weeks ] [ Designated as safety issue: No ]
    Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)

  • Change in specific cardiovascular risk factors [ Time Frame: For the duration of participant involvement in the study, maximum of 25 weeks ] [ Designated as safety issue: Yes ]
    Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results

  • Measure of risk of falls [ Time Frame: For the duration of participant involvement in the study, maximum 25 weeks ] [ Designated as safety issue: No ]
    Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lower dose of levothyroxine
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
Drug: Levothyroxine
Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Standard dose of levothyroxine
Patients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L)
Drug: Levothyroxine
Participants in the standard dose of treatment will receive their usual dose of levothyroxine

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647750

Contacts
Contact: Salman Razvi 0191 445 6052 salman.razvi@ghnt.nhs.uk
Contact: Melinda Jeffels 0191 222 7249 melinda.jeffels@newcastle.ac.uk

Locations
United Kingdom
Bensham Hospital Recruiting
Gateshead, Tyne and Wear, United Kingdom, NE8 4YL
Contact: Lorna Ingoe       lorna.ingoe@ghnt.nhs.uk   
Principal Investigator: Salman Razvi         
Clinical Research Facility Recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Contact: Valerie Corrall    01912464672    CRF.DRN-study@ncl.ac.uk   
Contact: Sarah Groves    0191 282 0084    CRF.DRN-study@ncl.ac.uk   
Principal Investigator: Simon Pearce         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Salman Razvi Gateshead Health NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Salman Razvi, Chief Investigator, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01647750     History of Changes
Other Study ID Numbers: 5863, PB-PG-0610-22139, 2011-004425-27, ISRCTN16043724
Study First Received: July 16, 2012
Last Updated: June 21, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014