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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 15, 2017

Interventions

  • Drug: Iodinated contrast agents
    • Use of iodine contrast agents and doses following the decision of the treating physician.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 3 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor

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