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Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment

Information source: Walter Reed National Military Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Hypothyroidism.

Intervention: Levothyroxine (Drug); Desiccated thyroid extract (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Walter Reed National Military Medical Center

Overall contact:
Mohamed KM Shakir, MD, Phone: 301-295-5165, Email: mohamed.k.shakir.civ@health.mil

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

thyroid-symptom questionnaire

Wechsler Memory Scale-Version IV (WMS-IV)

Secondary outcome: Biochemical measures

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Mohamed KM Shakir, MD, Phone: 301-295-5165, Email: mohamed.k.shakir.civ@health.mil

Walter Reed National Military Medical Center, Bethesda, Maryland 20889-5600, United States; Recruiting
Mohamed KM Shakir, MD, Phone: 301-295-5165, Email: mohamed.shakir@med.navy.mil
Patrick W Clyde, MD, Phone: 301-295-5165, Email: patrick.clyde@med.navy.mil
Thanh D Hoang, DO, Sub-Investigator

Walter Reed National Military Medical Center, Endocrinology, Bethesda, Maryland 20889-5600, United States; Enrolling by invitation

Additional Information

Related publications:

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Starting date: May 2012
Last updated: December 3, 2012

Page last updated: August 23, 2015

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