Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment
NCT ID: NCT01739972
Last Updated: 2012-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2012-05-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Levothyroxine
Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.
Desiccated thyroid extract
Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.
Desiccated thyroid extract
Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.
Levothyroxine
Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range.
Interventions
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Levothyroxine
Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range.
Desiccated thyroid extract
Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients scheduled for deployment will be excluded.
18 Years
65 Years
ALL
No
Sponsors
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Walter Reed National Military Medical Center
FED
Responsible Party
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Mohamed K.M. Shakir
Principal Investigator
Locations
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Walter Reed National Military Medical Center, Endocrinology
Bethesda, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Mohamed KM Shakir, MD
Role: primary
Patrick W Clyde, MD
Role: backup
References
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Cooper DS, Biondi B. Subclinical thyroid disease. Lancet. 2012 Mar 24;379(9821):1142-54. doi: 10.1016/S0140-6736(11)60276-6. Epub 2012 Jan 23.
Lowe JC. Stability, Effectivenes, and Safety of Desiccated Thyroid vs Levothyroxine: A Rebuttal to the British Thyroid Association. Thyroid Science 2009;4:C1-12.
Sawin CT, Hershman JM, Fernandez-Garcia R, Ghazvinian S, Ganda OP, Azukizawa M. A comparison of thyroxine and desicatted thyroid in patients with primary hypothyroidism. Metabolism. 1978 Oct;27(10):1518-25. doi: 10.1016/s0026-0495(78)80024-9. No abstract available.
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Kim BW, Bianco AC. For some, L-thyroxine replacement might not be enough: a genetic rationale. J Clin Endocrinol Metab. 2009 May;94(5):1521-3. doi: 10.1210/jc.2009-0410. No abstract available.
Panicker V, Saravanan P, Vaidya B, Evans J, Hattersley AT, Frayling TM, Dayan CM. Common variation in the DIO2 gene predicts baseline psychological well-being and response to combination thyroxine plus triiodothyronine therapy in hypothyroid patients. J Clin Endocrinol Metab. 2009 May;94(5):1623-9. doi: 10.1210/jc.2008-1301. Epub 2009 Feb 3.
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Escobar-Morreale HF, Botella-Carretero JI, Escobar del Rey F, Morreale de Escobar G. REVIEW: Treatment of hypothyroidism with combinations of levothyroxine plus liothyronine. J Clin Endocrinol Metab. 2005 Aug;90(8):4946-54. doi: 10.1210/jc.2005-0184. Epub 2005 May 31.
Appelhof BC, Fliers E, Wekking EM, Schene AH, Huyser J, Tijssen JG, Endert E, van Weert HC, Wiersinga WM. Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial. J Clin Endocrinol Metab. 2005 May;90(5):2666-74. doi: 10.1210/jc.2004-2111. Epub 2005 Feb 10.
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Escobar-Morreale HF, Botella-Carretero JI, Gomez-Bueno M, Galan JM, Barrios V, Sancho J. Thyroid hormone replacement therapy in primary hypothyroidism: a randomized trial comparing L-thyroxine plus liothyronine with L-thyroxine alone. Ann Intern Med. 2005 Mar 15;142(6):412-24. doi: 10.7326/0003-4819-142-6-200503150-00007.
Walsh JP, Shiels L, Lim EM, Bhagat CI, Ward LC, Stuckey BG, Dhaliwal SS, Chew GT, Bhagat MC, Cussons AJ. Combined thyroxine/liothyronine treatment does not improve well-being, quality of life, or cognitive function compared to thyroxine alone: a randomized controlled trial in patients with primary hypothyroidism. J Clin Endocrinol Metab. 2003 Oct;88(10):4543-50. doi: 10.1210/jc.2003-030249.
Clyde PW, Harari AE, Getka EJ, Shakir KM. Combined levothyroxine plus liothyronine compared with levothyroxine alone in primary hypothyroidism: a randomized controlled trial. JAMA. 2003 Dec 10;290(22):2952-8. doi: 10.1001/jama.290.22.2952.
Sawka AM, Gerstein HC, Marriott MJ, MacQueen GM, Joffe RT. Does a combination regimen of thyroxine (T4) and 3,5,3'-triiodothyronine improve depressive symptoms better than T4 alone in patients with hypothyroidism? Results of a double-blind, randomized, controlled trial. J Clin Endocrinol Metab. 2003 Oct;88(10):4551-5. doi: 10.1210/jc.2003-030139.
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Other Identifiers
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WalterReedNMMC
Identifier Type: -
Identifier Source: org_study_id