NCT00677469

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

Enrollment Period

6 months

First QC Date

May 12, 2008

Last Update Submit

May 13, 2008

Conditions

Graves Disease

Keywords

HyperthyroidismCholestyramine

Study Arms (3)

I

EXPERIMENTAL

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

Drug: Cholestyramine

II

EXPERIMENTAL

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

Drug: Cholestyramine

III

PLACEBO COMPARATOR

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

Drug: Placebo powder

Interventions

CholestyramineDRUG

2 grams BID

I
Placebo powderDRUG

1 gram BID

III

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with newly diagnosed hyperthyroid Graves' disease

You may not qualify if:

  • If the patient had been treated previously
  • diabetes, kidney, or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrine and Metabolism Research Center

Shiraz, Fars, Iran

Location

Related Publications (1)

  • 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.

    PMID: 18946743DERIVED

MeSH Terms

Conditions

Graves DiseaseHyperthyroidism

Interventions

Cholestyramine Resin

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PolystyrenesPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Golamhossein Omrani, M.D.

    Endocrine and Metabolism Research Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

July 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

IR(1)