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

Completed

Conditions studied: Hypothyroidism

In brief

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.

Key facts

Study ID

NCT02959827

Run by

Bayer

People needed

2320

Starts

2016-10-15

Expected to finish

2017-06-15

Last updated by the study team

2019-01-30

Who can join

Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Oakland — Oakland, California, United States

Full record on ClinicalTrials.gov

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