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Primary Hypothyroidism. | Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment

Primary Hypothyroidism. research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Primary Hypothyroidism.

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Drug:Desiccated thyroid extractArmour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Unknown status

Start Date: May 2012

Completed Date: May 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: thyroid-symptom questionnaire

Secondary Outcome: Biochemical measures

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Walter Reed National Military Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01739972

Roberts CG, Ladenson PW. Hypothyroidism. Lancet. 2004 Mar 6;363(9411):793-803. Review.

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