Thyroxine Titration Study

The aim of the study is to examine the effects of fine titration of thyroxine dosage on symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of hypothyroidism, wellbeing and quality of life will be improved in thyroxine-treated subjects when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to when TSH is in the upper reference range.

Official Title

What is the Optimal Serum TSH Concentration During Thyroxine Treatment for Primary Hypothyroidism? Effects of Fine Titration of Thyroxine Dosage on Wellbeing, Quality of Life and Cognitive Function.

Conditions

Hypothyroidism

Study Type

Interventional

Study Design

Treatment, Randomised, Double-Blind, Dose Comparison, Crossover Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

• Visual analog scales assessing wellbeing

Secondary Outcome Measures:

• Treatment satisfaction score
• Treatment preference
• Quality of life scores
• Cognitive function tests
• Clinical and biochemical markers of thyroid hormone action

Study Start

April 2003

Eligibility & Criteria

• Ages Eligible for Study: 18 years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects >18 years of age
• Primary hypothyroidism ≥6 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment
• Thyroxine dose ≥100 mcg/day
• No change in thyroxine dose in past 2 months
• Serum TSH of 0.1-4.8 mU/L
• Adequate contraceptive measures for women of childbearing age

Exclusion Criteria:

• Major systemic illness affecting quality of life or likely to affect participation in the study
• Treatment with T3 currently or in past 2 months
• History of thyroid cancer requiring suppression of TSH secretion by thyroxine
• Ischaemic heart disease – previous myocardial infarction, angina or coronary artery revascularisation
• Renal failure: serum creatinine >135 micromol/L
• Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range
• Bony fracture in past 3 months or Paget’s disease of bone
• Secondary (central) hypothyroidism or hypopituitarism.

Total Enrolment

55

Contact Details

Sir Charles Gairdner Hospital    
Nedlands, Western Australia, Australia, 6009