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NCT02567877 · ClinicalTrials.gov registry record
Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?
A clinical trial, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- 12
- Enrollment target
NCT02567877: Clinical Trial study, sponsored by University of Colorado, Denver.
NCT02567877 is a clinical trial that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02567877 was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- 12 participants
- Enrollment target
Study Summary
Patients taking thyroid hormone replacement after thyroid removal surgery often report feeling differently than they did prior to taking thyroid hormone. The symptoms can include fatigue, worsening mood or subjective "brain fog" where the patient feels like their thinking is just not as sharp as it was previously. Multiple studies have found that patients taking thyroid hormone replacement have a diminished quality of life compared to matched controls. Previous studies have suggested that the type of deiodinase (DIO) polymorphism a patient has, which is responsible for converting the thyroid hormone T4 into the more biologically active T3, may contribute to their overall cognition and sense of well-being. The Investigators aim to determine if the type of deiodinase polymorphism a patient has contributes to the patient's cognition and overall sense of well-being after surgery and thyroid hormone replacement. Objective: Determine if patients with the deiodinase type 2 CC polymorphism have objective differences in working memory (N-back test is primary endpoint), cognitive function and sense of well-being after thyroidectomy when placed on standard thyroid hormone replacement therapy. Hypotheses: (1) Patients with the deiodinase type 2 CC polymorphism will have worse working memory (N-back test is primary endpoint), cognitive function and sense of well-being on standard thyroid hormone replacement therapy after thyroidectomy compared with before thyroidectomy. (2) Patients with the deiodinase type 2 TT or TC polymorphism will have no differences in working memory, cognitive function or sense of well-being on standard thyroid hormone replacement before and after thyroidectomy.
Primary Outcome
Change in working memory as assessed by pre- vs post-surgery N-back test scores will be measured and compared between those with the deiodinase type 2 CC polymorphism versus those in the deiodinase type 2 TC and TT polymorphism group
Interventions
- PROCEDURE thyroidectomy
- DRUG levothyroxine in thyroidectomy patients
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-11 |
| Est. Completion | 2020-06 |
Why NCT02567877 stopped before completion
NCT02567877 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which thyroidectomy is the first listed.
NCT02567877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02567877 about?
NCT02567877 is a clinical study titled "Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?". Patients taking thyroid hormone replacement after thyroid removal surgery often report feeling differently than they did prior to taking thyroid hormone. The symptoms can include fatigue, worsening mood or subjective "brain fog" where the patient feels like their thinking is just not as sharp as it ...
What is the current status of trial NCT02567877?
This trial is currently terminated. The enrollment target is 12 participants. The study started on 2016-11. Estimated completion is 2020-06.
What interventions are being tested in trial NCT02567877?
The interventions under investigation include: thyroidectomy (PROCEDURE), levothyroxine in thyroidectomy patients (DRUG).
Who is sponsoring clinical trial NCT02567877?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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