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Effects of discontinuation of levothyroxine treatment in older adults: a self-controlled study.

Effects of discontinuation of levothyroxine treatment in older adults: a self-controlled study. - RELEASE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52395
Enrollment
415
Registered
2019-08-19
Start date
2020-02-13
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypothyroidism

Interventions

Stepwise levothyroxine treatment discontinuation. Levothyroxine at a dose of

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Community dwelling patients and nursing home patients aged 60 and over using levothyroxine continuously for a minimum of 1 year at a stable dose.

Exclusion criteria

Exclusion criteria: - Last measurement of TSH (thyroid stimulating hormone) >=10 mU/L during levothyroxine treatment - A history of thyroidectomy, radioactive iodine treatment, neck irradiation, congenital hypothyroidism or secondary hypothyroidism - Concurrent amiodarone or lithium use - Concurrent use of liothyronine, thiamazole, carbimazole or propylthiouracil. - Patients using a dose of more than 150 mcg levothyroxine per day - Diagnosis of heart failure NYHA grade IV - Diagnosis of dementia - Incapacitated adults - Life-expectancy of less than 6 months - Participation in ongoing trials of therapeutic interventions - Persons that plan to move out of the region in which the study is being conducted in the next months

Design outcomes

Primary

MeasureTime frame
The primary outcome is the proportion of participants that withdraw their thyroid medication successfully (defined as normal fT4 levels and TSH levels

Secondary

MeasureTime frame
Effects of discontinuing levothyroxine on: - Thyroid-related quality of life including somatic, psychological and social domains - General health - Treatment satisfaction for medication - Daily functioning Proportion of levothyroxine users who can achieve a substantial dose lowering of their levothyroxine dose after one year. 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. 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 . Physicians* experience on the recruitment of patients and the consultations, Study participants* experience of discontinuation of medication.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)