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| Sponsor: | Oregon Health and Science University |
|---|---|
| Information provided by: | Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00565864 |
Purpose
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 adn 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. These results may help physicians caring for patients with thyroid disease better determine the optimal dose of thyroid hormone for each patient.
| Condition | Intervention |
|---|---|
|
Hypothyroidism |
Drug: L-thyroxine (L-T4) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Dose Comparison Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Neurocognitive and Metabolic Effects of Mild Hypothyroidism |
| Estimated Enrollment: | 350 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1-A: Experimental
Subjects with baseline TSH between 0.28 and 2.49. Treatment arm 1-A targets a THS of 0.28 -2.49 mU/L (the theoretical optimal range).
|
Drug: L-thyroxine (L-T4)
L-thyroxine at doses appropriate to attain target TSH levels for the different arms for 24 weeks
|
|
1-B: Experimental
Subjects with baseline TSH levels between 0.28 and 2.49 mU/L, Treatment arm 1-B targeting a TSH of 2.5 - 5.0 mU/L
|
Drug: L-thyroxine (L-T4)
L-thyroxine at doses appropriate to attain target TSH levels for the different arms for 24 weeks
|
|
1-C: Experimental
Subjects with baseline TSH levels between 0.28 and 2.49 mU/L. Treatment arm 1- C is targeting a TSH level o f 5.1-12.0 mU/L
|
Drug: L-thyroxine (L-T4)
L-thyroxine at doses appropriate to attain target TSH levels for the different arms for 24 weeks
|
|
2-A: Experimental
Subjects with baseline TSH between 2.5 adn 5.0 mU/L. Treatment arm 2-A targets a THS of 0.28 -2.49 mU/L (the theoretical optimal range).
|
Drug: L-thyroxine (L-T4)
L-thyroxine at doses appropriate to attain target TSH levels for the different arms for 24 weeks
|
|
2-B: Experimental
Subjects with baseline TSH between 2.5 adn 5.0 mU/L. Treatment arm 2-B targeting a TSH of 2.5 - 5.0 mU/L
|
Drug: L-thyroxine (L-T4)
L-thyroxine at doses appropriate to attain target TSH levels for the different arms for 24 weeks
|
|
2-C: Experimental
Subjects with baseline TSH between 2.5 adn 5.0 mU/L. Treatment arm 1- C is targeting a TSH level o f 5.1-12.0 mU/L
|
Drug: L-thyroxine (L-T4)
L-thyroxine at doses appropriate to attain target TSH levels for the different arms for 24 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: Mary Samuels, MD 503-494-3273 samuelsm@ohsu.edu | |
| Principal Investigator: Mary Samuels, MD | |
| Sub-Investigator: Kathryn Schuff, MD | |
| Sub-Investigator: Jeri Janowsky, PhD | |
| Sub-Investigator: Nicole Carlson, PhD | |
| Principal Investigator: | Mary Samuels, MD | Oregon Health and Science University |
More Information
| Responsible Party: | Oregon Health & Science University ( Mary H. Samuels, M.D. ) |
| Study ID Numbers: | IRB00002265, PPQ IRB00002265 |
| Study First Received: | November 28, 2007 |
| Last Updated: | September 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00565864 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Hypothyroidism Cognition Metabolism |
|
Endocrine System Diseases Hypothyroidism Thyroid Diseases |
