REduction of LEvothyroxine in Adults; a SElf Controlled Study (NCT05821881) | Clinical Trial Compass
UnknownNot Applicable
REduction of LEvothyroxine in Adults; a SElf Controlled Study
Netherlands513 participantsStarted 2020-02-13
Plain-language summary
Many older persons use the thyroid hormone levothyroxine which is often continued for life. Scientifically, there is much uncertainty whether simple continuation is the optimal approach. The goal of this self-controlled observational study is to investigate how many participants of 60 years and older who are currently using levothyroxine, can be successfully withdrawn from levothyroxine treatment, either fully or partially, while maintaining a normal thyroid function (defined as a free T4 level within the reference range and a thyroid stimulating hormone \[TSH\] level \<10 mU/L), 52 weeks after the start of the discontinuation.
Levothyroxine treatment is discontinued gradually guided by the participant's general practitioner, using a step-wise approach with regular monitoring of thyroid function. In addition, the effects of discontinuation of levothyroxine on thyroid-specific quality of life and general health will be studied using questionnaires.
Who can participate
Age range60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 60 years or over (≥ 60 years)
✓. Using any levothyroxine mono-therapy medicament (ATC: H03AA01) continuously for a minimum of 1 year with stable dose of levothyroxine.
Exclusion criteria
✕. Last measurement of TSH ≥10 mU/L during levothyroxine treatment
✕. Current reason for levothyroxine treatment: patients with history of thyroidectomy; radioactive iodine treatment or neck irradiation; congenital hypothyroidism; secondary hypothyroidism, or concurrent amiodarone or lithium use
✕. Dose of treatment; for safety issues, patients using \> 150 mcg levothyroxine per day will not be eligible
✕. Concurrent treatment with liothyronine (the synthetic form of thyroid hormone T3), thiamazole, carbimazole or propylthiouracil (inhibitors of T3 and T4 synthesis).
✕. Diagnosis of heart failure NYHA grade IV
✕. Participation in ongoing trials of therapeutic interventions
✕
What they're measuring
1
Proportion of participants successfully withdrawn from levothyroxine treatment
Timeframe: 52 weeks after start of discontinuation