Primary Hypothyroidism.DTENCT01739972
Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment
A study testing Levothyroxine and Desiccated thyroid extract in people with Primary Hypothyroidism., run by Walter Reed National Military Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Hypothyroidism.
- What is being tested?
- Levothyroxine and Desiccated thyroid extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Enrolling by invitation
Walter Reed National Military Medical Center, Endocrinology
Bethesda, Maryland, 20889-5600
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Mohamed KM Shakir, MD, 301-295-5165, mohamed.shakir@med.navy.mil
Patrick W Clyde, MD, 301-295-5165, patrick.clyde@med.navy.mil
About this study
Official title: Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover 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.
- Conditions
- Primary Hypothyroidism.
- Being tested
- Levothyroxine, Desiccated thyroid extract
- Keywords
- Desiccated thyroid extract and levothyroxine
- Medical subject headings
- Hypothyroidism, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Synthroid
Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range.
Desiccated thyroid extractDrug
Also called Armour Thyroid
Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Active comparator | Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range. Receives: Drug: Desiccated thyroid extract |
| Desiccated thyroid extract | Active comparator | Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range. Receives: Drug: Levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid-symptom questionnaire
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.
Measured: 4 months
Wechsler Memory Scale-Version IV (WMS-IV)
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.
Measured: 4 months
Secondary outcomes (1)
Biochemical measures
Biochemical testing consisting of serum TSH, free T4, total T4, total T3, T3 resin uptake, sex hormone binding globulin (SHBG), and a lipid panel.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Primary Hypothyroidism.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Mohamed K.M. Shakir, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739972
- Sponsor's protocol ID
- WalterReedNMMC
- Acronym
- DTE
- Status last verified
- Nov 2012
- First submitted
- 28 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roberts CG, Ladenson PW. Hypothyroidism. Lancet. 2004 Mar 6;363(9411):793-803. doi: 10.1016/S0140-6736(04)15696-1.
PubMed 15016491Cooper DS, Biondi B. Subclinical thyroid disease. Lancet. 2012 Mar 24;379(9821):1142-54. doi: 10.1016/S0140-6736(11)60276-6. Epub 2012 Jan 23.
PubMed 22273398Lowe JC. Stability, Effectivenes, and Safety of Desiccated Thyroid vs Levothyroxine: A Rebuttal to the British Thyroid Association. Thyroid Science 2009;4:C1-12.
Sawin CT, Hershman JM, Fernandez-Garcia R, Ghazvinian S, Ganda OP, Azukizawa M. A comparison of thyroxine and desicatted thyroid in patients with primary hypothyroidism. Metabolism. 1978 Oct;27(10):1518-25. doi: 10.1016/s0026-0495(78)80024-9. No abstract available.
PubMed 99633Biondi B, Wartofsky L. Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism? J Clin Endocrinol Metab. 2012 Jul;97(7):2256-71. doi: 10.1210/jc.2011-3399. Epub 2012 May 16.
PubMed 22593590Celi FS, Zemskova M, Linderman JD, Smith S, Drinkard B, Sachdev V, Skarulis MC, Kozlosky M, Csako G, Costello R, Pucino F. Metabolic effects of liothyronine therapy in hypothyroidism: a randomized, double-blind, crossover trial of liothyronine versus levothyroxine. J Clin Endocrinol Metab. 2011 Nov;96(11):3466-74. doi: 10.1210/jc.2011-1329. Epub 2011 Aug 24.
PubMed 21865366Hennemann G, Docter R, Friesema EC, de Jong M, Krenning EP, Visser TJ. Plasma membrane transport of thyroid hormones and its role in thyroid hormone metabolism and bioavailability. Endocr Rev. 2001 Aug;22(4):451-76. doi: 10.1210/edrv.22.4.0435.
PubMed 11493579Salvatore D, Bartha T, Harney JW, Larsen PR. Molecular biological and biochemical characterization of the human type 2 selenodeiodinase. Endocrinology. 1996 Aug;137(8):3308-15. doi: 10.1210/endo.137.8.8754756.
PubMed 8754756Kim BW, Bianco AC. For some, L-thyroxine replacement might not be enough: a genetic rationale. J Clin Endocrinol Metab. 2009 May;94(5):1521-3. doi: 10.1210/jc.2009-0410. No abstract available.
PubMed 19420275Panicker V, Saravanan P, Vaidya B, Evans J, Hattersley AT, Frayling TM, Dayan CM. Common variation in the DIO2 gene predicts baseline psychological well-being and response to combination thyroxine plus triiodothyronine therapy in hypothyroid patients. J Clin Endocrinol Metab. 2009 May;94(5):1623-9. doi: 10.1210/jc.2008-1301. Epub 2009 Feb 3.
PubMed 19190113Nygaard B, Jensen EW, Kvetny J, Jarlov A, Faber J. Effect of combination therapy with thyroxine (T4) and 3,5,3'-triiodothyronine versus T4 monotherapy in patients with hypothyroidism, a double-blind, randomised cross-over study. Eur J Endocrinol. 2009 Dec;161(6):895-902. doi: 10.1530/EJE-09-0542. Epub 2009 Aug 7.
PubMed 19666698Grozinsky-Glasberg S, Fraser A, Nahshoni E, Weizman A, Leibovici L. Thyroxine-triiodothyronine combination therapy versus thyroxine monotherapy for clinical hypothyroidism: meta-analysis of randomized controlled trials. J Clin Endocrinol Metab. 2006 Jul;91(7):2592-9. doi: 10.1210/jc.2006-0448. Epub 2006 May 2.
PubMed 16670166Escobar-Morreale HF, Botella-Carretero JI, Escobar del Rey F, Morreale de Escobar G. REVIEW: Treatment of hypothyroidism with combinations of levothyroxine plus liothyronine. J Clin Endocrinol Metab. 2005 Aug;90(8):4946-54. doi: 10.1210/jc.2005-0184. Epub 2005 May 31.
PubMed 15928247Appelhof BC, Fliers E, Wekking EM, Schene AH, Huyser J, Tijssen JG, Endert E, van Weert HC, Wiersinga WM. Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial. J Clin Endocrinol Metab. 2005 May;90(5):2666-74. doi: 10.1210/jc.2004-2111. Epub 2005 Feb 10.
PubMed 15705921Saravanan P, Simmons DJ, Greenwood R, Peters TJ, Dayan CM. Partial substitution of thyroxine (T4) with tri-iodothyronine in patients on T4 replacement therapy: results of a large community-based randomized controlled trial. J Clin Endocrinol Metab. 2005 Feb;90(2):805-12. doi: 10.1210/jc.2004-1672. Epub 2004 Dec 7.
PubMed 15585551
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.
- ClinicalTrials.gov ID
- NCT01739972
- Acronym / sponsor ID
- DTE / WalterReedNMMC
- Conditions
- Primary Hypothyroidism.
- Keywords
- Desiccated thyroid extract and levothyroxine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- May 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Active comparator | Drug: Desiccated thyroid extractLevothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range. |
| Desiccated thyroid extract | Active comparator | Drug: LevothyroxineDesiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineAlso: SynthroidLevothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range. | Drug | Desiccated thyroid extract |
| Desiccated thyroid extractAlso: Armour ThyroidArmour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range. | Drug | Levothyroxine |
Primary outcome
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.
1 secondary outcome
Biochemical measures
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Background: PubMed 15016491Roberts CG, Ladenson PW. Hypothyroidism. Lancet. 2004 Mar 6;363(9411):793-803. doi: 10.1016/S0140-6736(04)15696-1.
- Background: PubMed 22273398Cooper DS, Biondi B. Subclinical thyroid disease. Lancet. 2012 Mar 24;379(9821):1142-54. doi: 10.1016/S0140-6736(11)60276-6. Epub 2012 Jan 23.
- BackgroundLowe JC. Stability, Effectivenes, and Safety of Desiccated Thyroid vs Levothyroxine: A Rebuttal to the British Thyroid Association. Thyroid Science 2009;4:C1-12.
- Background: PubMed 99633Sawin CT, Hershman JM, Fernandez-Garcia R, Ghazvinian S, Ganda OP, Azukizawa M. A comparison of thyroxine and desicatted thyroid in patients with primary hypothyroidism. Metabolism. 1978 Oct;27(10):1518-25. doi: 10.1016/s0026-0495(78)80024-9. No abstract available.
- Background: PubMed 22593590Biondi B, Wartofsky L. Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism? J Clin Endocrinol Metab. 2012 Jul;97(7):2256-71. doi: 10.1210/jc.2011-3399. Epub 2012 May 16.
- Background: PubMed 21865366Celi FS, Zemskova M, Linderman JD, Smith S, Drinkard B, Sachdev V, Skarulis MC, Kozlosky M, Csako G, Costello R, Pucino F. Metabolic effects of liothyronine therapy in hypothyroidism: a randomized, double-blind, crossover trial of liothyronine versus levothyroxine. J Clin Endocrinol Metab. 2011 Nov;96(11):3466-74. doi: 10.1210/jc.2011-1329. Epub 2011 Aug 24.
- Background: PubMed 11493579Hennemann G, Docter R, Friesema EC, de Jong M, Krenning EP, Visser TJ. Plasma membrane transport of thyroid hormones and its role in thyroid hormone metabolism and bioavailability. Endocr Rev. 2001 Aug;22(4):451-76. doi: 10.1210/edrv.22.4.0435.
- Background: PubMed 8754756Salvatore D, Bartha T, Harney JW, Larsen PR. Molecular biological and biochemical characterization of the human type 2 selenodeiodinase. Endocrinology. 1996 Aug;137(8):3308-15. doi: 10.1210/endo.137.8.8754756.
- Background: PubMed 19420275Kim BW, Bianco AC. For some, L-thyroxine replacement might not be enough: a genetic rationale. J Clin Endocrinol Metab. 2009 May;94(5):1521-3. doi: 10.1210/jc.2009-0410. No abstract available.
- Background: PubMed 19190113Panicker V, Saravanan P, Vaidya B, Evans J, Hattersley AT, Frayling TM, Dayan CM. Common variation in the DIO2 gene predicts baseline psychological well-being and response to combination thyroxine plus triiodothyronine therapy in hypothyroid patients. J Clin Endocrinol Metab. 2009 May;94(5):1623-9. doi: 10.1210/jc.2008-1301. Epub 2009 Feb 3.
- Background: PubMed 19666698Nygaard B, Jensen EW, Kvetny J, Jarlov A, Faber J. Effect of combination therapy with thyroxine (T4) and 3,5,3'-triiodothyronine versus T4 monotherapy in patients with hypothyroidism, a double-blind, randomised cross-over study. Eur J Endocrinol. 2009 Dec;161(6):895-902. doi: 10.1530/EJE-09-0542. Epub 2009 Aug 7.
- Background: PubMed 16670166Grozinsky-Glasberg S, Fraser A, Nahshoni E, Weizman A, Leibovici L. Thyroxine-triiodothyronine combination therapy versus thyroxine monotherapy for clinical hypothyroidism: meta-analysis of randomized controlled trials. J Clin Endocrinol Metab. 2006 Jul;91(7):2592-9. doi: 10.1210/jc.2006-0448. Epub 2006 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxine and Desiccated thyroid extract in people with Primary Hypothyroidism., run by Walter Reed National Military Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed KM Shakir, MD (301-295-5165, mohamed.k.shakir.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thyroid-symptom questionnaire (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739972, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.