REduction of LEvothyroxine in Adults; a SElf controlled study
- Conditions
- Hypothyrodism
- Registration Number
- NL-OMON24126
- Lead Sponsor
- ZonMW HGOG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 360
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1) Aged 60 years or over (= 60 years)
2) Using any levothyroxine mono-therapy medicament (ATC: H03AA01) continuously for a minimum of 1 year with stable dose of levothyroxine.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1) Last measurement of TSH =10 mU/L during levothyroxine treatment
2) 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
3) Dose of treatment; for safety issues, patients using > 150 mcg levothyroxine per day (0.48%) will not be eligible
4) Diagnosis of heart failure NYHA grade IV
5) Participation in ongoing trials of therapeutic interventions
6) Life-expectancy of less than 6 months
7) Diagnosis of dementia
8) Incapacitated adults
9) Persons that plan to move out of the region in which the study is being conducted in the next months.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the proportion of participants that withdraw their thyroid medication successfully, defined as normal fT4 levels and TSH levels <10 mU/L, at 52 weeks after start of the discontinuation of levothyroxine.
- Secondary Outcome Measures
Name Time Method Effects of discontinuing levothyroxine on thyroid-related quality of life including somatic, psychological and social domains; general health; treatment satisfaction for medication; daily functioning. <br>The proportion of levothyroxine users who can achieve a substantial dose lowering of their levothyroxine dose after one year. <br>Demographic, clincal characteristics and attitudes towards discontinuation of those levothyroxine users aged 60 years and older willing to discontinue levothyroxine treatment and those successfully reducing their dosage. <br>Characteristics of persons aged 60 years and older that physicians consider safe to withdraw thyroid medication from, and medical reasons not to discontinue treatment. Frequency of discontinuation (or stepping-down) levothyroxine treatment by general practitioners in usual care . <br>Physicians’ experience on the recruitment of patients and the consultations. <br>Study participants’ experience of discontinuation of medication.