Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment

NCT01739972 | Unknown DMC

• 1 other identifier: WalterReedNMMC
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Primary Hypothyroidism.

Keywords

Desiccated thyroid extract and levothyroxine

Outcome Measures

Primary Outcomes (2)

• thyroid-symptom questionnaire

  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.

  4 months

• Wechsler Memory Scale-Version IV (WMS-IV)

  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.

  4 months

Secondary Outcomes (1)

• Biochemical measures

  4 months

Other Outcomes (3)

• Beck Depression Index

  4 months

• General health questionnaire-12

  4 months

• Clinical preference

  4 months

Study Arms (2)

Levothyroxine

ACTIVE COMPARATOR

Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.

Drug: Desiccated thyroid extract

Desiccated thyroid extract

ACTIVE COMPARATOR

Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.

Drug: Levothyroxine

Interventions

Levothyroxine DRUG

Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range.

Also known as: Synthroid

Desiccated thyroid extract

Desiccated thyroid extract DRUG

Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.

Also known as: Armour Thyroid

Levothyroxine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (2)

Walter Reed National Military Medical Center, Endocrinology

Bethesda, Maryland, 20889-5600, United States

ENROLLING BY INVITATION

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

RECRUITING

Related Publications (34)

• Roberts CG, Ladenson PW. Hypothyroidism. Lancet. 2004 Mar 6;363(9411):793-803. doi: 10.1016/S0140-6736(04)15696-1.

  PMID: 15016491 BACKGROUND

• 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.

  PMID: 22273398 BACKGROUND

• Lowe JC. Stability, Effectivenes, and Safety of Desiccated Thyroid vs Levothyroxine: A Rebuttal to the British Thyroid Association. Thyroid Science 2009;4:C1-12.

  BACKGROUND

• 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.

  PMID: 99633 BACKGROUND

• 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.

  PMID: 22593590 BACKGROUND

• 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.

  PMID: 21865366 BACKGROUND

• 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. doi: 10.1210/edrv.22.4.0435.

  PMID: 11493579 BACKGROUND

• 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. doi: 10.1210/endo.137.8.8754756.

  PMID: 8754756 BACKGROUND

• 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.

  PMID: 19420275 BACKGROUND

• 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.

  PMID: 19190113 BACKGROUND

• Nygaard B, Jensen EW, Kvetny J, Jarlov 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.

  PMID: 19666698 BACKGROUND

• 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. doi: 10.1210/jc.2006-0448. Epub 2006 May 2.

  PMID: 16670166 BACKGROUND

• 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.

  PMID: 15928247 BACKGROUND

• 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.

  PMID: 15705921 BACKGROUND

• 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. doi: 10.1210/jc.2004-1672. Epub 2004 Dec 7.

  PMID: 15585551 BACKGROUND

• 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.

  PMID: 15767619 BACKGROUND

• 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.

  PMID: 14557419 BACKGROUND

• 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.

  PMID: 14665656 BACKGROUND

• 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.

  PMID: 14557420 BACKGROUND

• 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. doi: 10.1056/NEJM199902113400603.

  PMID: 9971866 BACKGROUND

• 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. doi: 10.1017/S1461145700001826.

  PMID: 11343593 BACKGROUND

• 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. doi: 10.1136/bmj.4.5728.145.

  PMID: 4097650 BACKGROUND

• Lanni A, Moreno M, Lombardi A, Goglia F. Calorigenic effect of diiodothyronines in the rat. J Physiol. 1996 Aug 1;494 ( Pt 3)(Pt 3):831-7. doi: 10.1113/jphysiol.1996.sp021536.

  PMID: 8865078 BACKGROUND

• Jackson IM, Cobb WE. Why does anyone still use desiccated thyroid USP? Am J Med. 1978 Feb;64(2):284-8. doi: 10.1016/0002-9343(78)90057-8.

  PMID: 629277 BACKGROUND

• 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. doi: 10.1136/bmj.1.4759.624. No abstract available.

  PMID: 14905006 BACKGROUND

• 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. doi: 10.1172/JCI100529. No abstract available.

  PMID: 16694154 BACKGROUND

• 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. doi: 10.1172/JCI100492. No abstract available.

  PMID: 16694117 BACKGROUND

• 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. doi: 10.1172/JCI100237. No abstract available.

  PMID: 16693869 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.7326/0003-4819-101-1-18.

  PMID: 6428290 BACKGROUND

• 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. doi: 10.1007/BF00451724.

  PMID: 7841966 BACKGROUND

• BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

  PMID: 13688369 BACKGROUND

• 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.

  PMID: 20230158 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Hypothyroidism; Thyroid Diseases

Interventions

Thyroxine; Thyroid (USP)

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Mohamed KM Shakir, MD

CONTACT

301-295-5165; mohamed.k.shakir.civ@health.mil

Patrick W Clyde, MD

CONTACT

301-295-5165; patrick.w.clyde.mil@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 4, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

US (2)