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Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment (DTE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by 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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • thyroid-symptom questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    General health questionnaire - consists of 12 quality of life questions.

  • Clinical preference [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
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:
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 
Study First Received: November 28, 2012
Last Updated: December 3, 2012
Health Authority: United States: Federal Government

Keywords provided by 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 September 26, 2016