Study of Optimal Replacement of Thyroxine in the Elderly

NCT01647750 | Completed Phase 4 DMC

• 4 other identifiers: 5863PB-PG-0610-221392011-004425-27ISRCTN16043724
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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. 1.Some older people with hypothyroidism may have few symptoms.
2. 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. 3.If TSH levels are too low there may be a slight increased risk of problems such as brittle bones or an irregular heartbeat.

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• 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)

  Until completion of recruitment, approximately 24 months

Secondary Outcomes (7)

• Participant recruitment rate

  Until completion of recruitment, approximately 24 months

• Time to achieve desired TSH levels

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

• Medication compliance

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

• The acceptability of three patient completed questionnaires

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

• Assessment of mobility

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

Study Arms (2)

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

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)

Drug: Levothyroxine

Interventions

Levothyroxine DRUG

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

Lower dose of levothyroxine

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

Bensham Hospital

Gateshead, Tyne and Wear, NE8 4YL, United Kingdom

Location

Clinical Research Facility

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27766119 DERIVED

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Salman Razvi

  Gateshead Health NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 24, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

GB (2)