Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment

Not Applicable

• Conditions: Primary Hypothyroidism.
• Interventions: Drug: Levothyroxine; Drug: Desiccated thyroid extract

• Registration Number: NCT01739972
• Lead Sponsor: Walter Reed National Military Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Status Verified: 2012-11
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Study First Posted: 2012-12-04
• Last Update Posted: 2012-12-04
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Desiccated thyroid extract	Levothyroxine	Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.
Levothyroxine	Desiccated thyroid extract	Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.

Primary Outcome Measures

Name	Time	Method
thyroid-symptom questionnaire	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.
Wechsler Memory Scale-Version IV (WMS-IV)	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

Name	Time	Method
Biochemical measures	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.

Trial Locations

Locations (2)

Walter Reed National Military Medical Center, Endocrinology; 🇺🇸 Bethesda, Maryland, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States