HypothyroidismNCT02959827
Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
An observational study of Hypothyroidism, run by Bayer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Iodinated contrast agents
- How many people
- 2,320 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2016to 15 Jun 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypothyroidism
- Being tested
- Iodinated contrast agents
- Keywords
- Hypothyroidism,, children,, iodinated contrast agents,, retrospective cohort,, database
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodinated contrast agentsDrug
Use of iodine contrast agents and doses following the decision of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Iodinated contrast agents | Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent Receives: Drug: Iodinated contrast agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 365 days after a diagnostic scan with iodinated contrast agent
Time From First Iodinated Contrast to First Hypothyroidism Event
Measured: Up to 365 days after a diagnostic scan with iodinated contrast agent
Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure
Measured: Up to 365 days after a diagnostic scan with iodinated contrast agent
Classification of Hypothyroidism by Etiology
Measured: Up to 365 days after a diagnostic scan with iodinated contrast agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start15 Oct 2016
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959827
- Sponsor's protocol ID
- 19185
- Status last verified
- Jan 2019
- First submitted
- 11 Oct 2016
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
- ClinicalTrials.gov ID
- NCT02959827
- Acronym / sponsor ID
- 19185
- Conditions
- Hypothyroidism
- Keywords
- Hypothyroidism,, children,, iodinated contrast agents,, retrospective cohort,, database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,320 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iodinated contrast agents | – | Drug: Iodinated contrast agentsChildren under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodinated contrast agentsUse of iodine contrast agents and doses following the decision of the treating physician. | Drug | Iodinated contrast agents |
Primary outcome
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.
8 secondary outcomes
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
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
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
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
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
Time From First Iodinated Contrast to First Hypothyroidism Event
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
Classification of Hypothyroidism by Etiology
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypothyroidism
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice (time frame: In the 365 days post exposure to an iodinated contrast agent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.