Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment (DTE)
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ClinicalTrials.gov Identifier: NCT01739972 |
Recruitment Status
: Unknown
Verified November 2012 by Mohamed K.M. Shakir, Walter Reed National Military Medical Center.
Recruitment status was: Recruiting
First Posted
: December 4, 2012
Last Update Posted
: December 4, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Hypothyroidism. | Drug: Levothyroxine Drug: Desiccated thyroid extract | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (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. |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | May 2014 |
Estimated Study Completion Date : | May 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Levothyroxine
Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.
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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
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Active Comparator: Desiccated thyroid extract
Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.
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Drug: Levothyroxine
Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range.
Other Name: Synthroid
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- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739972
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 |
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 |
Publications:
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 |
First Posted: | December 4, 2012 Key Record Dates |
Last Update Posted: | December 4, 2012 |
Last Verified: | November 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 |