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NCT Number: NCT01647750

Study of Optimal Replacement of Thyroxine in the Elderly

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.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bensham Hospital, Gateshead, Tyne and Wear, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Levothyroxine

Drug

Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose

Primary outcomes

  1. 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)

Secondary outcomes

  1. Participant recruitment rate

    Time frame: Until completion of recruitment, approximately 24 months

    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.

  2. Time to achieve desired TSH levels

    Time frame: Until participant completion of SORTED 1 study, approximately within 24 weeks

    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)

  3. Medication compliance

    Time frame: For the duration of participant involvment in the study, maximum of 25 weeks

    Tablet count

  4. The acceptability of three patient completed questionnaires

    Time frame: For the duration of participant involvement in the study, maximum of 25 weeks

    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.

  5. Assessment of mobility

    Time frame: For the duration of participant involvement in this study, maximum of 25 weeks

    Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)

  6. Change in specific cardiovascular risk factors

    Time frame: For the duration of participant involvement in the study, maximum of 25 weeks

    Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results

  7. Measure of risk of falls

    Time frame: For the duration of participant involvement in the study, maximum 25 weeks

    Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study 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

Acronym: SORTED

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2012
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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