Hypothyroidism Nutritional, Metabolic, Endocrine
Conditions
Interventions
Withdrawal of levothyroxine from patients taking levothyroxine medication without documented overt hypothyroidism or serum thyroid-stimulating hormone (TSH) >10 mU/l
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients taking levothyroxine for more than 6 months 2. Aged 18 years and over 3. No documented serum TSH =10 mU/l recorded in electronic health records 4. Pregnancy, breastfeeding or with a plan for pregnancy within 6 months 5. No history of thyroidectomy, pituitary disease or thyroid cancer 6. No active ischaemic heart disease, arrhythmia or other condition that in the opinion of the principal investigator would render the withdrawal of thyroid hormone unsafe 7. No dementia, active psychotic or serious mental health condition 8. Ability to give written informed consent
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Serum thyroid stimulating hormone levels measured using chemiluminescent assay at 6 weeks after levothyroxine treatment withdrawal 2. Serum free thyroxine (FT4) levels measured using chemiluminescent assay at 6 weeks after levothyroxine treatment withdrawal | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in quality of life measured using thyroid-specific patient-reported outcome 39-item (ThyPRO-39) scoring at 6 weeks after levothyroxine treatment withdrawal 2. Proportion of recruitments versus patients invited at the start of the study measured using signed consent forms versus letters of invitation sent 3. Friends and family test measured using a subjective questionnaire at end of the study 4. Multivariate analysis of baseline demographics (sex, age), thyroid clinical features (prior TSH, duration of LT4 treatment) and biochemical parameters at 6 weeks (TSH, FT4) 5. Serum TSH measurements measured using electronic health records over 1 year 6. Number of levothyroxine prescriptions measured using electronic health records over 1 year | — |
Countries
England, United Kingdom
Outcome results
None listed