Trial Condition(s):
Hypothyroidism
Iodinated contrast agents and risk of hypothyroidism in young children in the United States
Bayer Identifier:
19185
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Oakland Oakland, United States, 94612 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Iodinated contrast agents and risk of hypothyroidism in young children in the United States
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
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.Timeframe: 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 cohortTimeframe: 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 cohortTimeframe: 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 cohortTimeframe: 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 cohortTimeframe: 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 cohortTimeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent
- Time from first iodinated contrast to first hypothyroidism eventTimeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent
- Classification of subclinical/manifest hypothyroidism by type of exposureTimeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent
- Classification of hypothyroidism by etiologyTimeframe: Up to 365 days after a diagnostic scan with iodinated contrast agent
Additional Information
Not Available
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