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

Bayer1 site in 1 country2,320 target enrollmentOctober 15, 2016

ConditionsHypothyroidism

InterventionsIodinated contrast agents

DrugsIodinated contrast agents

Overview

Phase: Not Applicable
Intervention: Iodinated contrast agents
Conditions: Hypothyroidism
Sponsor: Bayer
Enrollment: 2320
Locations: 1
Primary Endpoint: Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2016

End Date

June 15, 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Iodinated contrast agents

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

Intervention: Iodinated contrast agents

Outcomes

Primary Outcomes

Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice

Time Frame: In the 365 days post exposure to an iodinated contrast agent

Incidence density rates (IDR) were calculated as the number of cases over the person time at risk where the numerator was the number of cases and the denominator was the person years at risk.

Secondary Outcomes

Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)
Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure(Up to 365 days after a diagnostic scan with iodinated contrast agent)
Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)
Time From First Iodinated Contrast to First Hypothyroidism Event(Up to 365 days after a diagnostic scan with iodinated contrast agent)
Classification of Hypothyroidism by Etiology(Up to 365 days after a diagnostic scan with iodinated contrast agent)
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)
Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)