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Low Doses of Cholestyramine in the Treatment of Hyperthyroidism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00677469
First Posted: May 14, 2008
Last Update Posted: May 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shiraz University of Medical Sciences
  Purpose
The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis.Bile-salt sequestrants (ionic exchange resins) bind thyroid hormones in the intestine and thereby increase their fecal excretion. Based on these observations, the use of cholestyramine has been tried. The present study evaluates the effect of low doses of cholestyramine as an adjunctive therapy in the management of hyperthyroidism

Condition Intervention
Graves Disease Drug: Cholestyramine Drug: Placebo powder

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Low Doses of Cholestyramine in the Treatment of Hyperthyroidism

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Enrollment: 45
Study Start Date: July 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Cholestyramine 2g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Drug: Cholestyramine
2 grams BID
Experimental: II
Cholestyramine 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Drug: Cholestyramine
1 gram BID
Placebo Comparator: III
Placebo powder 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Drug: Placebo powder
1 gram BID

Detailed Description:

The gastrointestinal tract has a role in thyroid physiology. Thyroid hormone is metabolized mainly in the liver, where it is conjugated to glucurunides and sulfates. These conjugation products are then excreted in the bile. Free hormones are released in the intestine and finally reabsorbed, completing the enterohepatic circulation of thyroid hormone. A very small portion of the daily production of thyroxin (T4) and triiodothyronine (T3), less than 10 percent, is excreted in the stool (1-3). In people with normal thyroid function, this pathway of T4 and T3 recirculation contributes so little to hormone availability that patients who have gastrointestinal disease or are receiving drugs that decrease T4 absorption do not have abnormal thyroid function (4). However, the thyrotoxic states are characterized by an increased enterohepatic circulation of thyroid hormones, as well as an increased urinary and fecal excretion of both conjugated and free T4 (5,6).

Cholestyramine, an ionic exchange resin sequesters T4 in the intestine and increases its fecal excretion. These phenomena were proven in hamsters in mid 1960s (7). Experimentally, it has been shown that 50 mg of cholestyramine can bind approximately 3000 μg of T4 (8) and therefore can enhance the clearance of thyroid hormones. Because of the increased enterohepatic circulation of thyroid hormones during hyperthyroidism, attempts have been made to sequester these hormones in the intestine using ionic exchange resins (9-13). Cholestyramine therapy has been studied in the treatment of thyrotoxicosis as an adjunctive therapy to thionamides, and has been found to decrease thyroid hormone levels rapidly. In several trials, cholestyramine in combination with methimazole (MMI) or propylthiouracil, caused a more rapid decline in thyroid hormone levels than standard therapy with thionamides alone (9-11,13). In all of these trials, cholestyramine was dosed at 4 grams orally two to four times a day.

This study was conducted to examine the efficacy of combination therapy of lower doses of cholestyramine with MMI and propranolol for treating patients with Graves' hyperthyroidism.

  Eligibility

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed hyperthyroid Graves' disease

Exclusion Criteria:

  • If the patient had been treated previously
  • diabetes, kidney, or liver disease
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00677469


Locations
Iran, Islamic Republic of
Endocrine and Metabolism Research Center
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Chair: Golamhossein Omrani, M.D. Endocrine and Metabolism Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Golamhossein Ranjbar Omrani, Endocrine and Metabolism Research Center
ClinicalTrials.gov Identifier: NCT00677469     History of Changes
Other Study ID Numbers: 2590
First Submitted: May 12, 2008
First Posted: May 14, 2008
Last Update Posted: May 14, 2008
Last Verified: May 2008

Keywords provided by Shiraz University of Medical Sciences:
Hyperthyroidism
Cholestyramine

Additional relevant MeSH terms:
Graves Disease
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Cholestyramine Resin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents