check_circleStudy Completed

Hypothyroidism

Bayer Identifier:

19185

ClinicalTrials.gov Identifier:

NCT02959827

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

Both

Age

0 - 3 Years
  • - 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.

  • - 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
2320
Trial Dates
October 2016 - June 2017
Phase
N/A
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
OaklandOakland, 94612, United States

Primary Outcome

  • Incidence rate of hypothyroidism detected in routine clinical practice
    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.
    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 cohort
    date_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 cohort
    date_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 cohort
    date_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 cohort
    date_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 cohort
    date_rangeTime Frame:
    Up to 365 days after a diagnostic scan with iodinated contrast agent
  • Time from first iodinated contrast to first hypothyroidism event
    date_rangeTime Frame:
    Up to 365 days after a diagnostic scan with iodinated contrast agent
  • Classification of subclinical/manifest hypothyroidism by type of exposure
    date_rangeTime Frame:
    Up to 365 days after a diagnostic scan with iodinated contrast agent
  • Classification of hypothyroidism by etiology
    date_rangeTime Frame:
    Up to 365 days after a diagnostic scan with iodinated contrast agent

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
N/A