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Low Doses of Cholestyramine in the Treatment of Hyperthyroidism

NCT ID: NCT00677469

Last Updated: 2008-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Graves Disease

Keywords

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Hyperthyroidism Cholestyramine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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I

Cholestyramine 2g BID, Methimazole 10mg TID, and Propranolol 20mg BID

Group Type EXPERIMENTAL

Cholestyramine

Intervention Type DRUG

2 grams BID

II

Cholestyramine 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID

Group Type EXPERIMENTAL

Cholestyramine

Intervention Type DRUG

1 gram BID

III

Placebo powder 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID

Group Type PLACEBO_COMPARATOR

Placebo powder

Intervention Type DRUG

1 gram BID

Interventions

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Cholestyramine

2 grams BID

Intervention Type DRUG

Cholestyramine

1 gram BID

Intervention Type DRUG

Placebo powder

1 gram BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with newly diagnosed hyperthyroid Graves' disease

Exclusion Criteria

* If the patient had been treated previously
* diabetes, kidney, or liver disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Endocrine and Metabolism Research Center

Principal Investigators

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Golamhossein Omrani, M.D.

Role: STUDY_CHAIR

Endocrine and Metabolism Research Center

Locations

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Endocrine and Metabolism Research Center

Shiraz, Fars, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 18946743 (View on PubMed)

Other Identifiers

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2590

Identifier Type: -

Identifier Source: org_study_id