Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment (DTE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2012 by Mohamed K.M. Shakir, Walter Reed National Military Medical Center.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Mohamed K.M. Shakir, Walter Reed National Military Medical Center

ClinicalTrials.gov Identifier:

NCT01739972

First received: November 28, 2012

Last updated: December 3, 2012

Last verified: November 2012

History of Changes

Purpose

Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being/ quality of life equivalently compared with L-T4.

Condition	Intervention
Primary Hypothyroidism.	Drug: Levothyroxine Drug: Desiccated thyroid extract


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.

Resource links provided by NLM:

MedlinePlus related topics: Hypothyroidism Thyroid Diseases

Drug Information available for: Levothyroxine Levothyroxine sodium Thyroid

U.S. FDA Resources

Further study details as provided by Mohamed K.M. Shakir, Walter Reed National Military Medical Center:

Primary Outcome Measures:

thyroid-symptom questionnaire [ Time Frame: 4 months ]
Thyroid Symptom Questionnaire, a health-related quality-of-life questionnaire, that consists of 12 questions, presented in the same format as the GHQ-12, that asked patients how they felt over the last three months.
Wechsler Memory Scale-Version IV (WMS-IV) [ Time Frame: 4 months ]
The Wechsler Memory Scale-Version IV (WMS-IV) included auditory memory index, visual memory index, visual working memory index, immediate memory index and delayed memory index.

Secondary Outcome Measures:

Biochemical measures [ Time Frame: 4 months ]
Biochemical testing consisting of serum TSH, free T4, total T4, total T3, T3 resin uptake, sex hormone binding globulin (SHBG), and a lipid panel.

Other Outcome Measures:

Beck Depression Index [ Time Frame: 4 months ]
The BDI is a self-rating scale of 21 items, in which scores of 10 or less indicate normal mood variation and scores of 11 or more reflect increasing levels of depression. Clinically important depression is associated with scores of 20 or more.
General health questionnaire-12 [ Time Frame: 4 months ]
General health questionnaire - consists of 12 quality of life questions.
Clinical preference [ Time Frame: 4 months ]
At the completion of the study, each patient will be asked which treatment (the first or the second) he or she preferred.


Estimated Enrollment:	180
Study Start Date:	May 2012
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Levothyroxine Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.	Drug: Desiccated thyroid extract Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range. Other Name: Armour Thyroid
Active Comparator: Desiccated thyroid extract Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.	Drug: Levothyroxine Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range. Other Name: Synthroid

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months.

Exclusion Criteria:

Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old.
Patients scheduled for deployment will be excluded.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739972

Contacts


Contact: Mohamed KM Shakir, MD	301-295-5165	mohamed.k.shakir.civ@health.mil
Contact: Patrick W Clyde, MD	301-295-5165	patrick.w.clyde.mil@health.mil

Locations


United States, Maryland
Walter Reed National Military Medical Center, Endocrinology	Enrolling by invitation
Bethesda, Maryland, United States, 20889-5600
Walter Reed National Military Medical Center	Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Mohamed KM Shakir, MD 301-295-5165 mohamed.shakir@med.navy.mil
Contact: Patrick W Clyde, MD 301-295-5165 patrick.clyde@med.navy.mil
Sub-Investigator: Thanh D Hoang, DO

Sponsors and Collaborators

Walter Reed National Military Medical Center

More Information

Publications:

Roberts CG, Ladenson PW. Hypothyroidism. Lancet. 2004 Mar 6;363(9411):793-803. Review.

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. Review.

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.

Biondi B, Wartofsky L. Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism? J Clin Endocrinol Metab. 2012 Jul;97(7):2256-71. doi: 10.1210/jc.2011-3399. Epub 2012 May 16. Review.

Celi FS, Zemskova M, Linderman JD, Smith S, Drinkard B, Sachdev V, Skarulis MC, Kozlosky M, Csako G, Costello R, Pucino F. Metabolic effects of liothyronine therapy in hypothyroidism: a randomized, double-blind, crossover trial of liothyronine versus levothyroxine. J Clin Endocrinol Metab. 2011 Nov;96(11):3466-74. doi: 10.1210/jc.2011-1329. Epub 2011 Aug 24.

Hennemann G, Docter R, Friesema EC, de Jong M, Krenning EP, Visser TJ. Plasma membrane transport of thyroid hormones and its role in thyroid hormone metabolism and bioavailability. Endocr Rev. 2001 Aug;22(4):451-76. Review.

Salvatore D, Bartha T, Harney JW, Larsen PR. Molecular biological and biochemical characterization of the human type 2 selenodeiodinase. Endocrinology. 1996 Aug;137(8):3308-15.

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. Review.

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.

Nygaard B, Jensen EW, Kvetny J, Jarløv A, Faber J. Effect of combination therapy with thyroxine (T4) and 3,5,3'-triiodothyronine versus T4 monotherapy in patients with hypothyroidism, a double-blind, randomised cross-over study. Eur J Endocrinol. 2009 Dec;161(6):895-902. doi: 10.1530/EJE-09-0542. Epub 2009 Aug 7.

Grozinsky-Glasberg S, Fraser A, Nahshoni E, Weizman A, Leibovici L. Thyroxine-triiodothyronine combination therapy versus thyroxine monotherapy for clinical hypothyroidism: meta-analysis of randomized controlled trials. J Clin Endocrinol Metab. 2006 Jul;91(7):2592-9. Epub 2006 May 2.

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. Epub 2005 May 31. Review.

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. Epub 2005 Feb 10.

Saravanan P, Simmons DJ, Greenwood R, Peters TJ, Dayan CM. Partial substitution of thyroxine (T4) with tri-iodothyronine in patients on T4 replacement therapy: results of a large community-based randomized controlled trial. J Clin Endocrinol Metab. 2005 Feb;90(2):805-12. Epub 2004 Dec 7.

Escobar-Morreale HF, Botella-Carretero JI, Gómez-Bueno M, Galán 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.

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.

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.

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.

Bunevicius R, Kazanavicius G, Zalinkevicius R, Prange AJ Jr. Effects of thyroxine as compared with thyroxine plus triiodothyronine in patients with hypothyroidism. N Engl J Med. 1999 Feb 11;340(6):424-9.

Bunevicius R, Prange AJ. Mental improvement after replacement therapy with thyroxine plus triiodothyronine: relationship to cause of hypothyroidism. Int J Neuropsychopharmacol. 2000 Jun;3(2):167-174.

Smith RN, Taylor SA, Massey JC. Controlled clinical trial of combined triiodothyronine and thyroxine in the treatment of hypothyroidism. Br Med J. 1970 Oct 17;4(5728):145-8.

Lanni A, Moreno M, Lombardi A, Goglia F. Calorigenic effect of diiodothyronines in the rat. J Physiol. 1996 Aug 1;494 ( Pt 3):831-7.

Sturnick MI, Falcon-Lesses M. A comparison of the effect of desiccated thyroid and sodium levothyroxine on the serum protein-bound iodine. New Engl J Med 1961;264:608-9. 16. Jackson I, Cobb WE. Why Does Anyone Still Use Desiccated Thyroid USP? Am J Med 1978;64: 284-8.

ROBERTSON JD, KIRKPATRICK HF. Changes in basal metabolism, serumprotein-bound iodine, and cholesterol during treatment of hypothyroidism with oral thyroid and L-thyroxine sodium. Br Med J. 1952 Mar 22;1(4759):624-8.

Means JH, Lerman J, Salter WT. THE ROLE OF THYROXIN IODINE AND TOTAL ORGANIC IODINE IN THE CALORIGENIC ACTION OF WHOLE THYROID GLAND. J Clin Invest. 1933 Jul;12(4):683-8.

Thompson WO, McLellan LL, Thompson PK, Dickie LF. THE RATES OF UTILIZATION OF THYROXINE AND OF DESICCATED THYROID IN MAN: THE RELATION BETWEEN THE IODINE IN DESICCATED THYROID AND IN THYROXINE. J Clin Invest. 1933 Jan;12(1):235-46.

Thompson WO, Thompson PK, Brailey AG, Cohen AC. THE CALORIGENETIC ACTION OF THYROXIN AT DIFFERENT LEVELS OF BASAL METABOLISM IN MYXEDEMA. J Clin Invest. 1929 Aug;7(3):437-63.

McDowell I, Newell C. The General Health Questionnaire. Measuring Health. A Guide to Rating Scales and Questionnaires. 2nd Ed, Oxford, 1996

Cooper DS, Halpern R, Wood LC, Levin AA, Ridgway EC. L-Thyroxine therapy in subclinical hypothyroidism. A double-blind, placebo-controlled trial. Ann Intern Med. 1984 Jul;101(1):18-24.

Jaeschke R, Guyatt G, Cook D, Harper S, Gerstein HC. Spectrum of quality of life impairment in hypothyroidism. Qual Life Res. 1994 Oct;3(5):323-7.

BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71.

Benson N, Hulac DM, Kranzler JH. Independent examination of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): what does the WAIS-IV measure? Psychol Assess. 2010 Mar;22(1):121-30. doi: 10.1037/a0017767.

Wechsler DA. The Wechsler Memory Scale-III. 3rd ed. San Antonio, Tex:Psychological Corp;1997.


Responsible Party:	Mohamed K.M. Shakir, Principal Investigator, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:	NCT01739972 History of Changes
Other Study ID Numbers:	WalterReedNMMC
Study First Received:	November 28, 2012
Last Updated:	December 3, 2012

Keywords provided by Mohamed K.M. Shakir, Walter Reed National Military Medical Center:


Desiccated thyroid extract and levothyroxine

Additional relevant MeSH terms:


Hypothyroidism Thyroid Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on August 16, 2017

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