Recruiting

Desiccated Thyroid Extract & Levothyroxine

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT01739972

Conditions

Primary Hypothyroidism.

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Levothyroxine

Desiccated thyroid extract

Study Details

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.

Conditions

Primary Hypothyroidism.

Study ID

NCT01739972

Start date

May, 2012

Status verified date

Nov, 2012

Completion date

May, 2014

Anticipated

Primary completion date

May, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Levothyroxine

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

Desiccated thyroid extract

Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.

Primary outcome measure

  • thyroid-symptom questionnaire [ Time Frame: 4 months ]
  • Wechsler Memory Scale-Version IV (WMS-IV) [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Mohamed KM Shakir, MD

301-295-5165mohamed.k.shakir.civ@health.mil

Patrick W Clyde, MD

301-295-5165patrick.w.clyde.mil@health.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Mohamed KM Shakir, MD

301-295-5165mohamed.shakir@med.navy.mil

Patrick W Clyde, MD

301-295-5165patrick.clyde@med.navy.mil

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Dec 4, 2012

Last verified

Nov, 2012

Keywords

  • Desiccated thyroid extract and levothyroxine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2012-12-04.