Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment (DTE)

Walter Reed National Military Medical Center

Status: Unknown

Conditions: Primary Hypothyroidism.

Treatments: Drug: Desiccated thyroid extract; Drug: Levothyroxine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01739972

WalterReedNMMC

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

180 participants in 2 patient groups

Levothyroxine

Active Comparator group

Description:

Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.

Treatment:

Drug: Desiccated thyroid extract

Desiccated thyroid extract

Active Comparator group

Description:

Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.

Treatment:

Drug: Levothyroxine