Thyroid Replacement Options for Primary Hypothyroidism: -A Pilot Study
Thyroid Replacement Options-Pilot Study. To assess the feasibility and design of a large-scale Thyroid Replacement Options study of Australians aged 18-60 years who are dissatisfied with their wellbeing on levothyroxine (LT4) replacement for primary hypothyroidism.
QIMR Berghofer Medical Research Institute
40 participants
May 17, 2021
Interventional
Conditions
Summary
The overall aim of this research project is to conduct an open label sequential treatment pilot study to assess alternate thyroid replacement treatments to standard levothyroxine (LT4) treatment. Participants will be aged 18-60 years taking greater than or equal to 100mcg daily LT4 monotherapy for hypothyroidism at stable dose. Participants will receive 21 weeks of levotriiodothyronine/ liothyronine (LT4/LT3) combination treatment followed by 21 weeks of desiccated thyroid extract. Dose adjustment will occur 7-weekly, based on results of serum thyroid function testing. The primary outcome of the pilot study is to assess the feasibility and design of a large-scale randomized trial of thyroid hormone therapies with specific trial design aspects to be studied including recruitment; adherence to treatment regimen; participant and staff satisfaction with protocol; completeness of data; and adherence to study protocol. The secondary outcome is to assess the number of dose adjustments required for stable thyroid function using a dose adjustment algorithm. Participant reported outcomes will look at the difference in thyroid-specific quality of life scores measured at the end of each study phase compared with their baseline score.
Eligibility
Inclusion Criteria6
- Provide signed and dated informed consent form
- Willing to comply with all study procedures for the duration of the study
- Aged 18-60 years
- Have confirmed history of hypothyroidism (documented in medical record or confirmed by usual treating medical practitioner), either previous biochemical primary hypothyroidism, total thyroidectomy, or radioiodine ablation
- Currently taking LT4 (without any other thyroid hormone products) at a dose greater than or equal to 100 mcg daily of brand names Oroxine or Eutroxsig
- Have had recorded serum TSH concentration between 0.3 and 4.0 mU/L within the last three months of the screening visit, or completed after Screening Visit on their current LT4 dose and prior to being enrolled into the trial.
Exclusion Criteria15
- An individual who meets any of the below criteria will be excluded from participation in the study:
- Hypopituitarism
- History of thyroid cancer requiring suppression of TSH concentration
- Any active malignancy
- History of cardiac disease (coronary artery disease, arrhythmia, or heart failure)
- History of cirrhosis
- History of chronic kidney disease, stage 3 or higher
- Current T3-containing treatment
- Currently taking LT4 with brand name Eltroxin
- Planned or current pregnancy within the trial period
- Drug treatment known to affect thyroid hormone metabolism (including amiodarone, cholestyramine, systemic corticosteroids, propranolol, phenytoin, phenobarbital, carbamazepine, lithium, rifampicin, or biotin-containing supplements)
- Concurrent participation in another clinical trial
- Unable to provide consent
- Unable to read sufficiently to perform study tasks (i.e., study questionnaires)
- Significant concerns from the study team about the potential participant’s ability to complete, or safety during, the trial
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Interventions
Brief name: Thyroid hormones Arm 1- Levothyroxine (LT4)/ Liothyronine (LT3) combination Arm 2- Desiccated thyroid extract International Non-proprietary Name (INN) Arm 1 Levothyroxine (LT4 ) - (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid Liothyronine (LT3) - (2S)-2-amino-3-[4-(4-hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propanoic acid Arm 2 - The active pharmaceutical ingredients in desiccated thyroid extract are LT4 and LT3. The INN is the same as for Arm 1. Levothyroxine (LT4 ) - (2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoic acid Liothyronine (LT3) - (2S)-2-amino-3-[4-(4-hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propanoic acid Dose administration Participants will sequentially receive two 21 week phases of oral treatment with twice daily thyroid hormones tablets (i) LT4/LT3 combination, and (ii) desiccated thyroid extract. Dose adjustment will occur seven-weekly, based on results of serum thyroid function testing. Dosing of medications will be titrated to target TSH between 0.3-4.0 mU/L, and for free T4 and free T3 serum levels to be in the normal range (free T4 10-20 pmol/L, free T3 2.8-6.8 pmol/L) . Dosing will be increased or decreased in 25 mcg equivalent doses for levothyroxine. If thyroid function tests show under-treatment, the dose will be increased. If thyroid function tests show over-treatment, the dose will be decreased. We will monitor adherence to the intervention by asking participants to bring study medication to each visit. Pill counts will be performed every 7 weeks to compare with expected number of unused interventional product. At the end of each 21 week treatment phase any unused medication will be returned to the hospital pharmacy for destruction.
Locations(1)
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ACTRN12621000237886