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

Completed

• Conditions: Hypothyroidism
• Interventions: Drug: Iodinated contrast agents

• Registration Number: NCT02959827
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-11
• Study Start: 2016-10-15
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-15
• Results First Submitted: 2018-05-24
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Results First Posted: 2019-01-30
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2320

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice	In the 365 days post exposure to an iodinated contrast agent	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.

Secondary Outcome Measures

Name	Time	Method
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
Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure	Up to 365 days after a diagnostic scan with iodinated contrast agent
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
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
Time From First Iodinated Contrast to First Hypothyroidism Event	Up to 365 days after a diagnostic scan with iodinated contrast agent
Classification of Hypothyroidism by Etiology	Up to 365 days after a diagnostic scan with iodinated contrast agent
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
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

Trial Locations

Locations (1)

Oakland; 🇺🇸 Oakland, California, United States