Desiccated Thyroid Extract Versus Synthetic T3/T4 Combination (ThyrolarTM) Versus L-T4 Alone in the Therapy of Primary Hypothyroidism With Special Attention to the Gene Polymorphism
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|ClinicalTrials.gov Identifier: NCT02317926|
Recruitment Status : Unknown
Verified May 2015 by Mohamed K.M. Shakir, Walter Reed National Military Medical Center.
Recruitment status was: Recruiting
First Posted : December 17, 2014
Last Update Posted : May 6, 2015
The proposed study design is a prospective, randomized, double-blind, crossover study. After informed consent is obtained, patients will be randomized to receive either desiccated thyroid in capsules, or L-T4/L-T3 (ThyrolarTM) in capsules, or L-T4 alone capsules. All study participants, physician investigators, those administering the neurocognitive tests and those analyzing test results will be blinded throughout the study.
Subjects will undergo memory testing, a disease specific symptom questionnaire, a general mental health assessment, a complete physical examination, baseline EKG, and biochemical testing consisting of serum TSH, free T4, total T4, total T3, free T3, T3 resin uptake, reverse T3, sex hormone binding globulin (SHBG), serum iodine, a lipid panel, insulin, glucose and leptin. This testing and DXA scan of body composition will be performed at baseline and after each 3 month treatment period. Deiodinase type 2 (DIO2) polymorphisms analyses - will also be performed at the beginning of the study and the results will be blinded to the investigators performing the memory testing.
After 5-6 weeks on the study medication, TSH levels will be checked and the medication adjusted to maintain TSH level between 0.46-4.68 mIU/L. Once the TSH level is in the desired range, subjects will continue the medication for an additional 6 weeks. Subjects will then be crossed-over to the other treatment arm for 3 months. Again, testing will be performed after each treatment period. Finally the subjects will again switched over to the 3rd arm and testing will be performed after treatment period.
A cross-over design is preferred because we are assessing subjective symptoms such as clinical well-being and other parameters. Therefore, we will be able to evaluate the effectiveness of L-T4/T3 (ThyrolarTM) vs DTE vs T4 alone in the same patientssubjects. This is also supported by the previous study by Escobar-Morreale et al.
Additionally, the Wechsler memory scale, DEXA for body composition, measurment of reverse T3, insulin, leptin, and DIO2 polymorphisms analysis will be included for the research portion of this study. Further, the frequency of serum blood draws, for research purposes, will be at intervals of 0, 6, 12, 18, 24, 30 and 36 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Hypothyroidism||Drug: Levothyroxine Drug: Levothyroxine Plus Liothyronine Drug: Desiccated Thyroid Extract||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2018|
Active Comparator: Levothyroxine Plus Liothyronine Group
Levothyroxine Plus Liothyronine Group
Drug: Levothyroxine Plus Liothyronine
Active Comparator: Levothyroxine Group
Active Comparator: Desiccated Thyroid Extract Group
Desiccated Thyroid Extract Group
Drug: Desiccated Thyroid Extract
- Wechsler memory scale, fourth edition (WMS-IV) [ Time Frame: 3 months ]Pearson, PsychCorp, San Antonio, Texas
- Beck Depression Inventory [ Time Frame: 3 months ]Pearson, PsychCorp
- Thyroid Symptom Questionnaire (TSQ) [ Time Frame: 3 months ]Clyde PW, Harari AE, Getka EJ, Shakir KM. Combined levothyroxine plus liothyronine compared with levothyroxine alone in primary hypothyroidism: a randomized controlled trial. JAMA. 2003; 290:2952-2958.
- QOL as measured by General Health Questionnaire (GHQ)-12 [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317926
|Contact: Mohamed K Shakir, MDfirstname.lastname@example.org|
|Contact: Angela Tayloremail@example.com|
|United States, Maryland|
|Walter Reed National Military Medical Center||Recruiting|
|Besthesda, Maryland, United States, 20889|
|Contact: Mohamed K Shakir, MD 301-295-5165 firstname.lastname@example.org|
|Contact: Angela Taylor 301-295-5165 email@example.com@mail.mil|