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

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ClinicalTrials.gov Identifier: NCT02959827
Recruitment Status : Completed
First Posted : November 9, 2016
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Hypothyroidism Drug: Iodinated contrast agents

Study Design
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Study Type : Observational
Actual Enrollment : 2320 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Actual Study Start Date : October 15, 2016
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Groups and Cohorts
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Group/Cohort Intervention/treatment
Iodinated contrast agents
Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent
 Drug: Iodinated contrast agents
Use of iodine contrast agents and doses following the decision of the treating physician.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959827


Locations
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United States, California
Oakland
Oakland, California, United States, 94612
Sponsors and Collaborators
Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol and Statistical Analysis Plan  [PDF] October 11, 2016

More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02959827    
Other Study ID Numbers: 19185
First Posted: November 9, 2016    Key Record Dates
Results First Posted: January 30, 2019
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Hypothyroidism,
children,
iodinated contrast agents,
retrospective cohort,
database
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases