REduction of LEvothyroxine in Adults; a SElf Controlled Study

NCT05821881 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 513

Last updated 2023-04-20

No results posted yet for this study

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to investigate how many participants of 60 years and older who are currently using levothyroxine, can be successfully withdrawn from levothyroxine treatment, either fully or partially, while maintaining a normal thyroid function (defined as a free T4 level within the reference range and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.

Conditions

Interventions

OTHER

Discontinuation of levothyroxine treatment

Step-wise reduction of levothyroxine treatment guided by thyroid function and symptoms

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER
  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Jacobijn Gussekloo, MD, PhD · Leiden University Medical Center

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05821881 on ClinicalTrials.gov