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:

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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. 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.

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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 June 22, 2017

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