Trial Outcomes & Findings for Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States (NCT NCT02959827)

NCT ID: NCT02959827

Last Updated: 2019-01-30

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 2320 participants
• Primary outcome timeframe: In the 365 days post exposure to an iodinated contrast agent
• Results posted on: 2019-01-30

Participant Flow

This study was a retrospective cohort study, using the data from the years 2008 to June of 2016 in the database of Kaiser Permanente Northern California.

There were 2320 children identified in Kaiser Permanente Northern California who met our study population criteria: patients who had a procedure that used iodinated contrast agent and were under the age of 4, during the years 2008 to June of 2016.

Participant milestones

Measure	Iodine Contrast Agent Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.
Overall Study STARTED	2320
Overall Study COMPLETED	2320
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Iodine Contrast Agent n=2320 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.
Age, Customized <1 month	197 Participants n=5 Participants
Age, Customized 1 to 3 months	174 Participants n=5 Participants
Age, Customized 3 to 6 months	174 Participants n=5 Participants
Age, Customized 6 months to 1 year	257 Participants n=5 Participants
Age, Customized 1 to 4 years	1518 Participants n=5 Participants
Sex: Female, Male Female	1032 Participants n=5 Participants
Sex: Female, Male Male	1288 Participants n=5 Participants
Race/Ethnicity, Customized White	800 Participants n=5 Participants
Race/Ethnicity, Customized African American	174 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	726 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific islander	425 Participants n=5 Participants
Race/Ethnicity, Customized Other or missing	195 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Iodine Contrast Agent n=2320 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice	15.9 events per 1,000 person years Interval 11.2 to 22.0	—

SECONDARY outcome

Timeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent

Outcome measures

Measure	Iodine Contrast Agent n=34 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases n=2286 Participants Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort <1 month	4 Participants	193 Participants
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort 1 to 3 months	6 Participants	168 Participants
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort 3 to 6 months	6 Participants	168 Participants
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort 6 months to 1 year	4 Participants	253 Participants
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort 1 to 4 years	14 Participants	1504 Participants

SECONDARY outcome

Timeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent

Outcome measures

Measure	Iodine Contrast Agent n=34 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases n=2286 Participants Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort Male	24 Participants	1264 Participants
Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort Female	10 Participants	1022 Participants

SECONDARY outcome

Timeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent

Outcome measures

Measure	Iodine Contrast Agent n=34 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases n=2286 Participants Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort 2008	4 Participants	300 Participants
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort 2009	3 Participants	320 Participants
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort 2010	9 Participants	297 Participants
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort 2011	2 Participants	260 Participants
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort 2012	2 Participants	266 Participants
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort 2013	4 Participants	263 Participants
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort 2014	4 Participants	234 Participants
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort 2015	6 Participants	241 Participants
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort through August 2016	0 Participants	105 Participants

SECONDARY outcome

Timeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent

Outcome measures

Measure	Iodine Contrast Agent n=34 Iodine contrast exposure Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases n=2290 Iodine contrast exposure Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort CT scan	18 Iodine contrast exposure	1762 Iodine contrast exposure
Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort Heart catheterization	16 Iodine contrast exposure	528 Iodine contrast exposure

SECONDARY outcome

Timeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent

Outcome measures

Measure	Iodine Contrast Agent n=34 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases n=2286 Participants Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort White	13 Participants	787 Participants
Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort African American	4 Participants	170 Participants
Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort Hispanic	6 Participants	720 Participants
Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort Asian/Pacific islander	9 Participants	416 Participants
Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort Other or missing	2 Participants	193 Participants

SECONDARY outcome

Timeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent

Outcome measures

Measure	Iodine Contrast Agent n=18 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases n=16 Participants Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Time From First Iodinated Contrast to First Hypothyroidism Event <30 days	4 Participants	3 Participants
Time From First Iodinated Contrast to First Hypothyroidism Event 30 - 59 days	4 Participants	3 Participants
Time From First Iodinated Contrast to First Hypothyroidism Event 60+ days	10 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent

Outcome measures

Measure	Iodine Contrast Agent n=18 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases n=16 Participants Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure Subclinical hypothyroidism	15 Participants	9 Participants
Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure Manifest hypothyroidism	2 Participants	1 Participants
Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure Treatment or diagnosis with no TSH test	1 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent

Outcome measures

Measure	Iodine Contrast Agent n=34 Participants Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure.	Non-hypothyroidism Cases Participants who did not meet the criteria to be a case of hypothyroidism were identified.
Classification of Hypothyroidism by Etiology Iodine induced cases	23 Participants	—
Classification of Hypothyroidism by Etiology Other etiology cases	11 Participants	—

Adverse Events

Iodine Contrast Agent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head

Bayer

Phone: (+) 1-888-8422937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER