Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment (DTE)

December 3, 2012 updated by: Mohamed K.M. Shakir, Walter Reed National Military Medical Center

Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889-5600
        • Recruiting
        • Walter Reed National Military Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Thanh D Hoang, DO
      • Bethesda, Maryland, United States, 20889-5600
        • Enrolling by invitation
        • Walter Reed National Military Medical Center, Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Synthroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
General health questionnaire-12
Time Frame: 4 months
General health questionnaire - consists of 12 quality of life questions.
4 months
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed National Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WalterReedNMMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Hypothyroidism.

Clinical Trials on Desiccated thyroid extract

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe