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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
Sponsor:
Information provided by (Responsible Party):
Mohamed K.M. Shakir, Walter Reed National Military Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Hypothyroidism. Drug: Levothyroxine Drug: Desiccated thyroid extract Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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:
  1. 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.

  2. General health questionnaire-12 [ Time Frame: 4 months ]
    General health questionnaire - consists of 12 quality of life questions.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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Information from the National Library of Medicine

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


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
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Publications:
Lowe JC. Stability, Effectivenes, and Safety of Desiccated Thyroid vs Levothyroxine: A Rebuttal to the British Thyroid Association. Thyroid Science 2009;4:C1-12.
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.
McDowell I, Newell C. The General Health Questionnaire. Measuring Health. A Guide to Rating Scales and Questionnaires. 2nd Ed, Oxford, 1996
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
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