Clinical trial NCT01739972: Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment
Official title: Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Hypothyroidism.
Keywords: Desiccated thyroid extract and levothyroxine
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2012-12-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: thyroid-symptom questionnaire
timeFrame: 4 months
measure: Wechsler Memory Scale-Version IV (WMS-IV)
timeFrame: 4 months
Secondary outcomes:
measure: Biochemical measures
timeFrame: 4 months
Other outcomes:
measure: Beck Depression Index
timeFrame: 4 months
measure: General health questionnaire-12
timeFrame: 4 months
measure: Clinical preference
timeFrame: 4 months
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center, Endocrinology
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References:
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