Combination T4/T3 trial for hypothyroidism

Phase 4

• Conditions: Hypothyroidism; Metabolic and Endocrine - Thyroid disease

• Registration Number: ACTRN12622000106730
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Adults (over age >18y) with confirmed hypothyroidism defined as previous total thyroidectomy, previous radioiodine treatment with TSH > 4 post radioiodine treatment, or confirmed hypothyroidism with at least two TSH measurements >10 mU/L or at least one TSH measurement >20 mU/L.

Individuals with persistent symptoms (>6 months) that are not explained by inadequate treatment of hypothyroidism, low adherence to T4, or other overt co-morbidity and that the individual believes are related to inadequate treatment of hypothyroidism. Eligible individuals will have at symptoms from at least 2 of the following broad groups: tiredness, fatigue, or lethargy (ThyPRO q2); difficult concentrating or thinking, poor memory, or brain fog” (ThyPRO q3); mood disturbance (ThyPRO q4-6); and bloating or difficulty maintaining weight (ThyPRO 9a). For each broad category, to be eligible individuals must answer Quite a bit or Very much” to at least one of the relevant ThyPRO questions.

Thyroxine monotherapy for at least 6 months, with measurements of TSH within the normal range for at least the preceding 3 months. Minor abnormalities of TSH (0.2-0.4 or 4-6 mu/L) will not exclude individuals from participating. The thyroxine dose must have been stable for at least the preceding 3 months.

Exclusion Criteria

Individuals who are asymptomatic or have symptoms from only 1 of the 4 broad groups outlined in the inclusion criteria or do not meet the criteria for severity of symptoms outlined in the inclusion criteria.

Individuals with symptoms they attribute to inadequately treated hypothyroidism that do not fall within the categories outlined in the inclusion criteria.

Individuals with poorly controlled hypothyroidism, defined as TSH <0.2 or >6 within the last 3 months.

Individuals with significant co-morbidity, in which their symptoms are more likely to be caused by their co-morbidity than hypothyroidism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the difference in hypothyroidism-specific quality of life as measured using composite scores from the ThyPRO tool in periods of combination thyroxine and liothyronine compared with ThyPRO scores during thyroxine and placebo treatment.[Thypro scores are measured every 2 weeks for 52 weeks.]

Secondary Outcome Measures

Name	Time	Method
Overall quality of life impact as measured using the ThyPRO tool in periods of combination thyroxine and liothyronine compared with overall quality of life impact scores during thyroxine and placebo treatment.[Overall quality of life impact scores are measured every 2 weeks for 52 weeks.];Hypothyroid physical symptoms as measured using the ThyPRO tool in periods of combination thyroxine and liothyronine compared with overall quality of life impact scores during thyroxine and placebo treatment.[Hypothyroid physical symptoms are measured every 2 weeks for 52 weeks.];Each individual component of hypothyroidism-specific quality of life as measured by the ThyPRO tool in periods of combination thyroxine and liothyronine compared with ThyPRO scores during thyroxine and placebo treatment.[Thypro scores are measured every 2 weeks for 52 weeks.]