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

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02959827
• Other study ID #: 19185
• Status: Completed
• Start date: October 15, 2016
• Est. completion date: June 15, 2017

Study information

• Verified date: January 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2320
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

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

Locations

Country	Name	City	State
United States	Oakland	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice	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.	In the 365 days post exposure to an iodinated contrast agent
Secondary	Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort		Up to 365 days after a diagnostic scan with iodinated contrast agent
Secondary	Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort		Up to 365 days after a diagnostic scan with iodinated contrast agent
Secondary	Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort		Up to 365 days after a diagnostic scan with iodinated contrast agent
Secondary	Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort		Up to 365 days after a diagnostic scan with iodinated contrast agent
Secondary	Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort		Up to 365 days after a diagnostic scan with iodinated contrast agent
Secondary	Time From First Iodinated Contrast to First Hypothyroidism Event		Up to 365 days after a diagnostic scan with iodinated contrast agent
Secondary	Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure		Up to 365 days after a diagnostic scan with iodinated contrast agent
Secondary	Classification of Hypothyroidism by Etiology		Up to 365 days after a diagnostic scan with iodinated contrast agent