Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-15

Study Completion Date

2017-06-15

Brief Summary

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This study will estimate the incidence of hypothyroidism in a pediatric population of children under age 4, based on data from the US-based Kaiser Permanente Northern California database, which were exposed to iodinated contrast agent through having a diagnostic procedure.

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Detailed Description

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Conditions

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Hypothyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Iodinated contrast agents

Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent

Iodinated contrast agents

Intervention Type DRUG

Use of iodine contrast agents and doses following the decision of the treating physician.

Interventions

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Iodinated contrast agents

Use of iodine contrast agents and doses following the decision of the treating physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children under age 4 in the Kaiser Permanente Northern California (KPNC) database, who had a diagnostic procedure with an iodinated contrast agent.
* Participants should be member of the KPNC for at least 3 months before the iodinated contrast exposure, except where the child is under 3 months of age at time of initial exposure, and 2 weeks after the exposure.

Exclusion Criteria

* Diagnosis of hypothyroid any time prior to the iodine contrast exposure.
* Lab values for low thyroid (TSH \> 5 mU/L for children) any time before the exposure
* Thyroid replacement therapy, Hashimoto thyroiditis, or congenital hypothyroidism any time prior to exposure.

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No