NCT02959827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

October 15, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 30, 2019

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

October 11, 2016

Results QC Date

May 24, 2018

Last Update Submit

January 29, 2019

Conditions

Hypothyroidism

Keywords

Hypothyroidism,children,iodinated contrast agents,retrospective cohort,database

Outcome Measures

Primary Outcomes (1)

  • 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.

    In the 365 days post exposure to an iodinated contrast agent

Secondary Outcomes (8)

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

    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

    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

    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

    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

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

  • +3 more secondary outcomes

Study Arms (1)

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

Interventions

Iodinated contrast agentsDRUG

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

Iodinated contrast agents

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oakland

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Results Point of Contact

Title
Therapeutic Area Head
Organization
Bayer
clinical-trials-contact@bayer.com
(+) 1-888-8422937

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

November 9, 2016

Study Start

October 15, 2016

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

January 30, 2019

Results First Posted

January 30, 2019

Record last verified: 2019-01

Locations

US(1)