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

Bayer

Status: Completed

Conditions: Hypothyroidism

Treatments: Drug: Iodinated contrast agents

Study type: Observational

Funder types: Industry

Identifiers

NCT02959827

19185

Details and patient eligibility

About

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.

Enrollment: 2,320 patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,320 participants in 1 patient group

Iodinated contrast agents

Description:

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

Treatment:

Drug: Iodinated contrast agents