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Dosing of LT4 in Older Individuals

ConditionHypothyroidism
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Pennsylvania

About this trial

Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, community dwelling, aged 65 years or older

Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last TSH test.

Disqualifiers

Hypopituitarism

History of thyroid cancer requiring suppression of TSH secretion

Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests

GFR <30 ml/min/1.73 m2 within the prior 12 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levothyroxine Sodium

    Drug

    Levothyroxine dose will depend on dose at baseline and randomization group

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: Lower TSH GroupActive comparator 1 intervention
Group B: Higher TSH groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale

22 items, scored 0-100, higher scores indicate worse status

Time frame
6 months

Secondary outcomes

1

Thyroid-Related Quality of Life Patient-Reported Outcome Hypothyroidism subscale b. ThyPRO "Tiredness" subscale c. Thyroid Symptoms Questionnaire (TSQ)

4 items, scored 0-100, higher scores indicate worse status

Time frame
6 months
2

NIH Toolbox Fluid Cognition Composite Score

Adjusted scale score, based around median of 100, higher scores indicated higher function

Time frame
6 months
3

Geriatric Depression Scale

30 items, higher scores indicate more depressive symptoms

Time frame
6 months
4

Pittsburgh Sleep Quality Index

19 items, range of 0-21, higher scores indicate worse sleep

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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