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CompletedNCT02375451Updated Jun 26, 2017

Effect of Childhood Radioiodine Therapy on Salivary Function

An observational study in Xerostomia, Hyperthyroidism and Thyroid Cancer, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 3 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-06-26.

Sponsored by Boston Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
70
Ages
3 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Xerostomia
  • Hyperthyroidism
  • Thyroid Cancer
03

In context

Xerostomia

264 studies on the registry are indexed under Xerostomia; 48 are open to participants now.

This study's enrollment of 70 is below the median of 100 across 33 observational studies indexed under Xerostomia.

Browse Xerostomia studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 149 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 19 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have receive I-131 therapy in childhood for thyroid disease, compared to a control group of patients who have never receive I-131 therapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Radioiodine

  • Control

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

Interventions

  • OtherRadioiodine

    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).

06

What researchers measure

Primary outcomes

  1. Salivary function (MST value)

    sterile paper strip is used to measure saliva production (noninvasive testing)

    Time frame: 0 to 50 years after radioiodine treatment

  2. Responses to Dry Mouth Questionnaire

    Patient questionnaire/survey

    Time frame: At time of visit up to 4 months thereafter.

Secondary outcomes

  1. Caries history (number of caries noted in dental records)

    Time frame: 1 year before radioiodine administration to 4 months after study visit.

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Study locations

1 site
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02375451
Responsible party
Ari Wassner (Director, Thyroid Program, Division of Endocrinology, Boston Children's Hospital) — Principal investigator
First posted
Mar 2, 2015
Start date
Sep 2014
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Jun 26, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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