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NCT00565864 · ClinicalTrials.gov registry record · Phase 4
Neurocognitive and Metabolic Effects of Mild Hypothyroidism
A Phase 4 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 4
- Development phase
- 173
- Enrollment target
NCT00565864 is a Phase 4 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 173 participants.
The verdict
NCT00565864, a Phase 4 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 173 participants
- Enrollment target
Study Summary
Patients with hypothyroidism are routinely treated with thyroid hormone (l-thyroxine) for replacement therapy. Physicians monitor the thyroid hormone dose by measuring a thyroid stimulating hormone (TSH) level in the blood, with the goal of a normal level. However, recent data suggest that the "normal" TSH range is too broad, and that patients may still have symptoms if their TSH levels are at the top or bottom part of the normal range. To study this issue, it is useful to address issues such as general health status, psychological symptoms, mood, memory, and metabolic status, since thyroid hormone has major effects on the brain and metabolism, and since patients with treated hypothyroidism often have symptoms related to these areas. In the present study, otherwise healthy subjects with treated hypothyroidism, ages 20-75 years, will be enrolled in a 7-11month study. At baseline, they will have tests of health status, psychological symptoms, mood, memory, body composition, and energy expenditure performed. Following these baseline measurements, subjects will receive either their usual doses of l-thyroxine, or a slightly higher or lower dose. The doses will be chosen to try to achieve either a low-normal TSH level, a high-normal TSH level, or a mildly elevated TSH level. Which target TSH the patient is assigned will be determined randomly, and neither the subject nor the study contacts will know which dose the patient is receiving. Subjects will be seen every 6 weeks during the study for brief visits to make sure they are not having any side effects, and to adjust the l-thyroxine doses if the TSH has not yet reached the target range. At the 24-week visit (end of study), the subjects will undergo the same tests that they had on the baseline visit. Results from the study will be examined to see if minor changes in TSH or other thyroid hormone levels cause changes in any of the outcomes, and if the degree of TSH change correlates with the degree of outcome changes. Th
Interventions
- DRUG L-thyroxine (L-T4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00565864
The ClinicalTrials.gov registry entry for NCT00565864 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which L-thyroxine (L-T4) is the first listed.
NCT00565864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00565864 about?
NCT00565864 is a clinical study titled "Neurocognitive and Metabolic Effects of Mild Hypothyroidism". Patients with hypothyroidism are routinely treated with thyroid hormone (l-thyroxine) for replacement therapy. Physicians monitor the thyroid hormone dose by measuring a thyroid stimulating hormone (TSH) level in the blood, with the goal of a normal level. However, recent data suggest that the "norm...
What is the current status of trial NCT00565864?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 173 participants. The study started on 2008-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00565864?
The interventions under investigation include: L-thyroxine (L-T4) (DRUG).
Who is sponsoring clinical trial NCT00565864?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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