N/A
N=2,320
Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Hypothyroidism
Bottom Line
View on ClinicalTrials.gov: NCT02959827 ↗Enrolled (actual)
2,320
Serious AEs
—
Results posted
Jan 2019
Primary outcome: Primary: Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice — 15.9 events per 1,000 person years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Iodinated contrast agents (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice |
15.9 | — |
| SECONDARY Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort |
4; 193; 6; 168; 6; 168 | — |
| SECONDARY Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort |
24; 1264; 10; 1022 | — |
| SECONDARY Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort |
4; 300; 3; 320; 9; 297 | — |
| SECONDARY Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort |
18; 1762; 16; 528 | — |
| SECONDARY Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort |
13; 787; 4; 170; 6; 720 | — |
| SECONDARY Time From First Iodinated Contrast to First Hypothyroidism Event |
4; 3; 4; 3; 10; 10 | — |
| SECONDARY Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure |
15; 9; 2; 1; 1; 6 | — |
| SECONDARY Classification of Hypothyroidism by Etiology |
23; 11 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02959827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.