Trial Condition(s):

Hypothyroidism

Iodinated contrast agents and risk of hypothyroidism in young children in the United States

Bayer Identifier:

19185

ClinicalTrials.gov Identifier:

NCT02959827

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
2320
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Oakland

Oakland, United States, 94612

Status
Completed
 

Trial Design