Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment

Overview

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.

Full Title of Study: “Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2014

Interventions

  • Drug: Levothyroxine
    • Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range.
  • Drug: Desiccated thyroid extract
    • Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.

Arms, Groups and Cohorts

  • Active Comparator: Levothyroxine
    • Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.
  • Active Comparator: Desiccated thyroid extract
    • Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.

Clinical Trial Outcome Measures

Primary Measures

  • thyroid-symptom questionnaire
    • Time Frame: 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)
    • Time Frame: 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 Measures

  • Biochemical measures
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Walter Reed National Military Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed K.M. Shakir, Principal Investigator – Walter Reed National Military Medical Center
  • Overall Contact(s)
    • Mohamed KM Shakir, MD, 301-295-5165, mohamed.k.shakir.civ@health.mil

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