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OpenTrials
Completed

NCT Number: NCT02959827

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

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.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oakland

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iodinated contrast agents

Drug

Use of iodine contrast agents and doses following the decision of the treating physician.

Primary outcomes

  1. Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice

    Time frame: 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.

Secondary outcomes

  1. Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort

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

  2. Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort

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

  3. Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort

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

  4. Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort

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

  5. Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort

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

  6. Time From First Iodinated Contrast to First Hypothyroidism Event

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

  7. Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure

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

  8. Classification of Hypothyroidism by Etiology

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2016
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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