Effect of Childhood Radioiodine Therapy on Salivary Function

NCT ID: NCT02375451

Last Updated: 2017-06-26

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease. We will use a Modified Shirmer Test to measure saliva production and a questionnaire to evaluation symptoms of xerostomia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Xerostomia Hyperthyroidism Thyroid Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radioiodine

Patients with a history of childhood treatment with radioiodine will be assessed for symptoms of salivary function and measurement of saliva production. These data will be compared to a normal control group.

Radioiodine

Intervention Type OTHER

We will determine if prior radioiodine treatment in childhood impacts salivary function or symptoms. Radioiodine treatment will have been determined by the patient's medical condition and care (NOT assigned by this research study).

Control

Patients who are similar in age to those in the Radioiodine group, but who did not recieve I-131 therapy.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radioiodine

We will determine if prior radioiodine treatment in childhood impacts salivary function or symptoms. Radioiodine treatment will have been determined by the patient's medical condition and care (NOT assigned by this research study).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who have been treated with radioiodine therapy
* Patients who have never received radioiodine therapy (negative control group)

Exclusion Criteria

* Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way.
Minimum Eligible Age

3 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ari Wassner

Director, Thyroid Program, Division of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-P00012399

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hyperthyroid Follow-Up Study
NCT02989103 COMPLETED