Effect of Childhood Radioiodine Therapy on Salivary Function
1 other identifier
observational
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2014
1 active site
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
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJune 26, 2017
June 1, 2017
2 years
October 3, 2014
June 23, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Salivary function (MST value)
sterile paper strip is used to measure saliva production (noninvasive testing)
0 to 50 years after radioiodine treatment
Responses to Dry Mouth Questionnaire
Patient questionnaire/survey
At time of visit up to 4 months thereafter.
Secondary Outcomes (1)
Caries history (number of caries noted in dental records)
1 year before radioiodine administration to 4 months after study visit.
Study Arms (2)
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.
Control
Patients who are similar in age to those in the Radioiodine group, but who did not recieve I-131 therapy.
Interventions
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).
Eligibility Criteria
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
You may qualify if:
- Patients who have been treated with radioiodine therapy
- Patients who have never received radioiodine therapy (negative control group)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Thyroid Program, Division of Endocrinology
Study Record Dates
First Submitted
October 3, 2014
First Posted
March 2, 2015
Study Start
September 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
June 26, 2017
Record last verified: 2017-06