check_circleStudy Completed
Hypothyroidism
Bayer Identifier:
19185
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Iodinated contrast agents and risk of hypothyroidism in young children in the United States
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.
Key Participants Requirements
Sex
BothAge
0 - 3 YearsTrial summary
Enrollment Goal
2320Trial Dates
October 2016 - June 2017Phase
N/ACould I Receive a placebo
NoProducts
Ultravist (Iopromide, BAY86-4877)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Oakland | Oakland, 94612, United States |
Primary Outcome
- Incidence rate of hypothyroidism detected in routine clinical practiceIncidence 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.date_rangeTime Frame:In the 365 days post exposure to an iodinated contrast agent
Secondary Outcome
- Baseline characteristics (age) of the cases with hypothyroidism and of the rest of the cohortdate_rangeTime Frame: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 cohortdate_rangeTime Frame: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 cohortdate_rangeTime Frame: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 cohortdate_rangeTime Frame:Up to 365 days after a diagnostic scan with iodinated contrast agent
- Baseline characteristics (race/ethnicity) of the cases with hypothyroidism and of the rest of the cohortdate_rangeTime Frame:Up to 365 days after a diagnostic scan with iodinated contrast agent
- Time from first iodinated contrast to first hypothyroidism eventdate_rangeTime Frame:Up to 365 days after a diagnostic scan with iodinated contrast agent
- Classification of subclinical/manifest hypothyroidism by type of exposuredate_rangeTime Frame:Up to 365 days after a diagnostic scan with iodinated contrast agent
- Classification of hypothyroidism by etiologydate_rangeTime Frame:Up to 365 days after a diagnostic scan with iodinated contrast agent
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A