NCT01862510

Brief Summary

The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

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

March 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

May 20, 2013

Last Update Submit

December 5, 2014

Conditions

Celiac DiseaseHypothyroidismCeliac SprueMalabsorption

Keywords

Celiac DiseaseHypothyroidismCeliac SprueMalabsorption

Outcome Measures

Primary Outcomes (1)

  • presence of celiac disease

    1 month

Secondary Outcomes (2)

  • Symptoms associated with celiac disease

    6 months

  • medication adjustment

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with hypothyroidism who take thyroid replacement therapy

You may qualify if:

  • Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy.

You may not qualify if:

  • Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

Related Publications (2)

  • Collins D, Wilcox R, Nathan M, Zubarik R. Celiac disease and hypothyroidism. Am J Med. 2012 Mar;125(3):278-82. doi: 10.1016/j.amjmed.2011.09.003.

    PMID: 22340926BACKGROUND

  • Zubarik R, Ganguly E, Nathan M, Vecchio J. Celiac disease detection in hypothyroid patients requiring elevated thyroid supplementation: A prospective cohort study. Eur J Intern Med. 2015 Dec;26(10):825-9. doi: 10.1016/j.ejim.2015.09.011. Epub 2015 Sep 28.

    PMID: 26423749DERIVED

MeSH Terms

Conditions

Celiac DiseaseHypothyroidismMalabsorption Syndromes

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesThyroid DiseasesEndocrine System Diseases

Study Officials

  • Richard Zubarik, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 24, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

US(1)