Low Doses of Cholestyramine in the Treatment of Hyperthyroidism
Primary Purpose
Graves Disease
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cholestyramine
Cholestyramine
Placebo powder
Sponsored by
About this trial
This is an interventional treatment trial for Graves Disease focused on measuring Hyperthyroidism, Cholestyramine
Eligibility Criteria
Inclusion Criteria:
- Patients with newly diagnosed hyperthyroid Graves' disease
Exclusion Criteria:
- If the patient had been treated previously
- diabetes, kidney, or liver disease
Sites / Locations
- Endocrine and Metabolism Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
I
II
III
Arm Description
Cholestyramine 2g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Cholestyramine 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Placebo powder 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00677469
First Posted
May 12, 2008
Last Updated
May 13, 2008
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00677469
Brief Title
Low Doses of Cholestyramine in the Treatment of Hyperthyroidism
Official Title
Low Doses of Cholestyramine in the Treatment of Hyperthyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease
Keywords
Hyperthyroidism, Cholestyramine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Description
Cholestyramine 2g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Arm Title
II
Arm Type
Experimental
Arm Description
Cholestyramine 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Arm Title
III
Arm Type
Placebo Comparator
Arm Description
Placebo powder 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID
Intervention Type
Drug
Intervention Name(s)
Cholestyramine
Intervention Description
2 grams BID
Intervention Type
Drug
Intervention Name(s)
Cholestyramine
Intervention Description
1 gram BID
Intervention Type
Drug
Intervention Name(s)
Placebo powder
Intervention Description
1 gram BID
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with newly diagnosed hyperthyroid Graves' disease
Exclusion Criteria:
If the patient had been treated previously
diabetes, kidney, or liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golamhossein Omrani, M.D.
Organizational Affiliation
Endocrine and Metabolism Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Endocrine and Metabolism Research Center
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
18946743
Citation
Kaykhaei MA, Shams M, Sadegholvad A, Dabbaghmanesh MH, Omrani GR. Low doses of cholestyramine in the treatment of hyperthyroidism. Endocrine. 2008 Aug-Dec;34(1-3):52-5. doi: 10.1007/s12020-008-9107-5. Epub 2008 Oct 23.
Results Reference
derived
Learn more about this trial
Low Doses of Cholestyramine in the Treatment of Hyperthyroidism
We'll reach out to this number within 24 hrs