Study of Optimal Replacement of Thyroxine in the Elderly

NCT ID: NCT01647750

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: OTHER

Levothyroxine

Intervention Type: DRUG

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)

Group Type: OTHER

Levothyroxine

Intervention Type: DRUG

Participants in the standard dose of treatment will receive their usual dose of levothyroxine

Interventions

Levothyroxine

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

Intervention Type: DRUG

Levothyroxine

Participants in the standard dose of treatment will receive their usual dose of levothyroxine

Intervention Type: DRUG

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)

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salman Razvi

Role: PRINCIPAL_INVESTIGATOR

Gateshead Health NHS Foundation Trust

Locations

Bensham Hospital

Gateshead, Tyne and Wear, United Kingdom

Clinical Research Facility

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 27766119 (View on PubMed)

Other Identifiers

PB-PG-0610-22139

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-004425-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISRCTN16043724

Identifier Type: REGISTRY

Identifier Source: secondary_id

5863

Identifier Type: -

Identifier Source: org_study_id