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

• Status: Completed
• Trial end date: 2017-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

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.