Thyroid Replacement Options for Primary Hypothyroidism: -A Pilot Study

Phase 2

Active, not recruiting

• Conditions: Hypothyroidism; Metabolic and Endocrine - Thyroid disease

• Registration Number: ACTRN12621000237886
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-05
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility - recruitment rate as assessed by study database.[At 42 weeks post enrolment of the last enrolled participant. ];Feasibility - adherence to treatment regime as assessed by study-specific questionnaire[Every 7 weeks post commencement of intervention. ];Design - participant satisfaction with protocol measured with study specific questionnaire.[Every 7 weeks post commencement of intervention. ]