Back to resultsDesiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment (DTE)
Primary Purpose
Primary Hypothyroidism.
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine
Desiccated thyroid extract
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypothyroidism. focused on measuring Desiccated thyroid extract and levothyroxine
Eligibility 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.
Sites / Locations
- Walter Reed National Military Medical Center, Endocrinology
- Walter Reed National Military Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Levothyroxine
Desiccated thyroid extract
Arm Description
Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.
Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.
Outcomes
Primary Outcome Measures
thyroid-symptom questionnaire
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)
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
Biochemical testing consisting of serum TSH, free T4, total T4, total T3, T3 resin uptake, sex hormone binding globulin (SHBG), and a lipid panel.
Full Information
NCT ID
NCT01739972
First Posted
November 28, 2012
Last Updated
December 3, 2012
Sponsor
Walter Reed National Military Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01739972
Brief Title
Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment
Acronym
DTE
Official Title
Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed National Military Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypothyroidism.
Keywords
Desiccated thyroid extract and levothyroxine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Levothyroxine
Arm Type
Active Comparator
Arm Description
Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.
Arm Title
Desiccated thyroid extract
Arm Type
Active Comparator
Arm Description
Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
Synthroid
Intervention Description
Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range.
Intervention Type
Drug
Intervention Name(s)
Desiccated thyroid extract
Other Intervention Name(s)
Armour Thyroid
Intervention Description
Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.
Primary Outcome Measure Information:
Title
thyroid-symptom questionnaire
Description
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.
Time Frame
4 months
Title
Wechsler Memory Scale-Version IV (WMS-IV)
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Biochemical measures
Description
Biochemical testing consisting of serum TSH, free T4, total T4, total T3, T3 resin uptake, sex hormone binding globulin (SHBG), and a lipid panel.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Beck Depression Index
Description
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.
Time Frame
4 months
Title
General health questionnaire-12
Description
General health questionnaire - consists of 12 quality of life questions.
Time Frame
4 months
Title
Clinical preference
Description
At the completion of the study, each patient will be asked which treatment (the first or the second) he or she preferred.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed KM Shakir, MD
Phone
301-295-5165
Email
mohamed.k.shakir.civ@health.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick W Clyde, MD
Phone
301-295-5165
Email
patrick.w.clyde.mil@health.mil
Facility Information:
Facility Name
Walter Reed National Military Medical Center, Endocrinology
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed KM Shakir, MD
Phone
301-295-5165
Email
mohamed.shakir@med.navy.mil
First Name & Middle Initial & Last Name & Degree
Patrick W Clyde, MD
Phone
301-295-5165
Email
patrick.clyde@med.navy.mil
First Name & Middle Initial & Last Name & Degree
Thanh D Hoang, DO
12. IPD Sharing Statement
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Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment
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