Attention Deficit With Hyperactivity DisorderTHYRADHDNCT05080491
Thyroid Profile in Attention Deficit With Hyperactivity Disorder (ADHD)
A study testing immuno analysis and neuropsychological tests in people with Attention Deficit With Hyperactivity Disorder, run by Fondation Lenval at 1 site in France.
Trial summary
Rationale: The observational data of University Children's Hospitals of Nice, suggest that about a quarter of children and adolescents with ADHD may present with an abnormal thyroid profile. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Attention Deficit With Hyperactivity Disorder
- What is being tested?
- immuno analysis and neuropsychological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys or girls aged by 7 and 17 years old included
- Diagnosed with ADHD according to DSM-5 criteria with either Inattentive predominant, Hyperactive-impulsive predominant or Combined presentations.
- Scoring at least 28 (maximum value 54) on the ADHD-RS total score that is the sum of 18 items each rated on a 0-3 scale.
- Scoring at least 4 (= Moderate) on the Clinical Global Impression - Severity scale
- Without any clinical symptom of either hypothyroidism or hyperthyroidism
- Who signed an informed consent form
- Whose at least of parents (or default a legal representative) signed an informed consent form
Who cannot join
- Known or concomitant diagnosis of Autism Spectrum Disorder according to DSM-5 criteria Known or concomitant diagnosis of Schizophrenia or Psychotic Disorder according to DSM-5 criteria Known or concomitant diagnosis of any thyroid disorder (hypothyroidism or hyperthyroidism) whatever the cause might be Known or concomitant diagnosis of any genetic condition affecting the thyroid function (e.g. Down syndrome)
- Intake in the last month of a psychotropic drug for:
- ADHD: methylphenidate, atomoxetine, dexamphetamine, lisdexamphetamine, guanfacine or clonidine.
- Any psychiatric disorder (antipsychotic, anxiolytics, antidepressant, etc.)
- Intake in the last month of a molecule affecting the thyroid function:
- Any compound containing thyroid hormones
Show all 10Show fewer
- Anti-thyroid drugs: carbimazole, thiamazole, propylthiouracil and perchlorate
- Any compound containing iodine
- Significant application on the skin of iodized products in the last six months
- Injection of water-soluble iodine contrast agents in the last 2 months or fat-soluble in the last 6 months
Trial locations and contacts
1 site in 1 country.
Dominique Donzeau, PhD contact
France1 site, 1 recruiting
- Recruiting
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, 06200
Hervé CACI,, MD PhD, 0492030392, caci.h@pediatrie-chulenval-nice.fr
Dominique Donzeau, PhD, donzeau.d@chu-nice.fr
About this study
Official title: Abnormal Thyroid Profile in Children With Attention Deficit With Hyperactivity Disorder (ADHD)
Rationale: The observational data of University Children's Hospitals of Nice, suggest that about a quarter of children and adolescents with ADHD may present with an abnormal thyroid profile.
Main objective: To confirm that a subsample of children and adolescents with ADHD present with an abnormal thyroid profile using the gold standard for free fraction of hormones : chromatography with mass spectrometry.
Read more
Secondary objective: To examine to what extent this categorization holds using classic immuno-analytic assays. To characterize clinically and from a neuropsychological point of view this subsample and compare it to the other participants.
Study duration and design: 30 months (24 months for inclusion and 6 months for data analyses) open-label, (category 2 : interventional research with minimal risks or constraints), multicentre, without treatment or placebo administration.
Expected outcomes: Ancillary studies will investigate genetic physiopathological mechanisms (polymorphisms of deiodase or transmembrane carriers of thyroid hormones) and link this profile to other biological markers proposed in the literature (low ferritinemia, higher oxidative stress, atopic comorbid disease). The clinical trajectory of this subgroup and the persistence of this abnormal thyroid profile in adulthood will be a relevant issue in the future.
Read the detailed description
Rationale: The internal observational data on 514 children and adolescents with ADHD suggest that 16-28% of them have an abnormal thyroid profile in immuno-analysis: normal free thyroid-stimulating hormone TSH and T4 but abnormally high free T3. Several pathophysiological hypotheses can be formulated, some of which relate to possible polymorphisms of the deiodase or transmembrane carriers of thyroid hormones, and also with other suspected biological markers of ADHD reported in the literature (low ferritin, atopic disease and oxidative stress). This abnormal thyroid profile may be an endophenotype of a subgroup of children and adolescents with ADHD. However, the reference technique for the determination of free fractions of hormones is chromatography with mass spectrometry and not immuno-analysis.
Main objective : To confirm by chromatography with mass spectrometry the existence of a subgroup of children and adolescents with ADHD with this abnormal thyroid profile.
Secondary objectives:
- Describe this subgroup by sex (male/female) and age (before 12 and after 12 years) clinically and neuropsychologically (Attention Network Task and Tower of London coupled with eye-tracking) and compare it with the rest of the sample.
- Dose thyroid hormones and TSH levels with 4 different techniques of immuno-analysis
- Calculate the classification concordance (abnormal profile / normal profile) between all pairs of dosage methods (chromatography and 4 immuno-analysis based techniques)
- Calculate 95% reference intervals for all assays and techniques throughout the sample.
Main evaluation criterion: free T3 greater than the 97.5 percentile of the reference interval in chromatography, free T4 between the 2.5 percentile and the 97.5 percentile with this same technique, and free TSH between the 2.5 percentile and the 97.5 percentile of the immuno-analytical reference interval.
Secondary evaluation criteria:
- Describe the subgroup and compare it to the rest of the sample:
- Number of criteria for inattention, hyperactivity-impulsivity and therefore clinical presentation of ADHD (Predominant Inattentive, Predominant Hyperactive-Impulsive, Combined)
- Scores for inattention, hyperactivity-impulsivity and their sum on the ADHD-Rating Scale and score on the Clinical Global Impression - Severity
- Pattern of comorbidities diagnosed with Kiddie-SADDS-PL, manual, ocular and pedestrian preference, presence of atopic disease
- Performance at the Attention Network Task and Test of the Tower of London coupled with eye-tracking
- Calculate the classification concordance all pairs of dosage methods (chromatography and 4 immuno-analysis based techniques): correlation, concordance indices 2x2 (for example, Cohen's kappa)
- Calculate 95% reference intervals with age as co-variable and separately for boys and girls.
Study duration: 30 months (24 months for inclusion and 6 months for data analyses) Study design: Open-label, cross-sectional (category 2 : interventional research with minimal risks or constraints), multicentre, no treatment or placebo administration.
Selection criteria:
- Inclusion criteria: Boys or girls aged 7 to 17 with ADHD (as per Diagnostic and Statistical Manual DSM-5 criteria).
- Criteria for Non-Inclusion:
- Known or concurrent diagnosis of Autism Spectrum Disorder, Schizophrenia or Psychotic Disorder (as determined by DSM-5), thyroid disease of any origin, genetic disease known to affect thyroid function.
- Any psychotropic treatment (for ADHD or others) in the month before inclusion or any treatment that may affect thyroid function
- Exclusion criteria: Withdrawal of informed consent by at least one of the child's parents or their legal representative.
Course of the study: The criteria for non-inclusion are checked, the diagnosis is confirmed using the Kiddie-SADS-PL before the child can be included. The patient's participation stops after the venous blood collection and the administration of two neuropsychological tests (Attention Network Task and Tower of London). The tubes are transported to the biochemistry laboratory of the CHU of Nice which prepares five aliquots (4 for assays in immuno-analysis including 2 on site, and one for assay in chromatography with mass spectrometry at the CHU of Toulouse).
Expected outcomes: The identification and clinical characterization of a subgroup of children and adolescents with ADHD with an abnormal thyroid profile will support the clinical diagnosis for these at least. Ancillary studies will investigate genetic physiopathological mechanisms (polymorphisms of deiodases or transmembrane carriers of thyroid hormones) and link this profile to other biological markers proposed in the literature (low ferritinemia, higher oxidative stress, atopic comorbid disease). The clinical trajectory of this subgroup and the persistence of this abnormal thyroid profile in adulthood will be relevant in the future
- Being tested
- immuno analysis and neuropsychological tests
- Keywords
- ADHD, thyroid, free-T3, triiodothyronine, free-T4, thyroxine, TSH, chromatography, immuno-analysis, child, adolescent
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immuno analysis and neuropsychological testsDiagnostic test
A venous blood sample will be taken for assay in immuno-analysis including and for assay in chromatography with mass spectrometry. Patients will participate in computer neuropsychological tests: .
Venous blood collection and the administration : the tubes are transported to the biochemistry laboratory of the University Hospital Center of Nice (CHU Nice) which prepares five aliquots (4 for assays in immuno-analysis including 2 on site, and one for assay in chromatography with mass spectrometry.
Administration of two neuropsychological tests on computer(Attention Network Task and Tower of London).
| Study group | Role | What they receive |
|---|---|---|
| Determination of thyroid profile and neuropsychological assessment | Experimental | Not described Receives: Diagnostic Test: immuno analysis and neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition of an abnormal thyroid profile
To confirm by chromatography with mass spectrometry the existence of a subgroup of children and adolescents with ADHD with this abnormal thyroid profile. Free T3 greater than the 97.5 percentile of the reference interval in chromatography, free T4 between the 2.5 percentile and the 97.5 percentile with this same technique, and free TSH between the 2.5 percentile and the 97.5 percentile of the immuno-analytical reference interval.
Measured: at inclusion
Secondary outcomes (7)
Describe the subgroup and compare it to pattern of comorbidities :ADHD Rating Scale
measure of number of criteria for inattention, hyperactivity-impulsivity and therefore clinical presentation of ADHD (Predominant Inattentive, Predominant Hyperactive-Impulsive, Combined)
ADHD Rating Scale: 9 inattention items and 9 hyperactivity-impulsivity items rated on a 0-3 scale (range 0-27), therefore the total score is on a 0-54 range. The higher the scores the higher the inattention and hyperactivity-impulsivity
Measured: at inclusion
Describe the subgroup and compare it to pattern of comorbidities :Kiddie-SADDS-PL
measure of pattern of comorbidities diagnosed with Kiddie-SADDS-PL, manual, ocular and pedestrian preference, presence of atopic disease
Kiddie-SADDS-PL: to make diagnoses according to DSM-V
Measured: at inclusion
Describe the subgroup and compare it to pattern of comorbidities: Performance at the Attention Network Task
Determination of performance at the Attention Network Task (ANT) coupled with eye-tracking
Three attention network will be assessed:
Alerting: (RT without cue) minus (RT double cue) Orienting: (RT central cue) minus (RT orienting cue) Conflict: (RT flanker incongruent) minus (RT flanker congruent)
Eye-tracking associated with ANT: On screen Areas Of Interest (AOI) are determined and for each of them the relative duration of gazing with be computed to build a patient-specific Task AOI : the fixation cross, cues and the target Peripheral AOI : the rest of the screen External AOI : outside the screen
Measured: at inclusion
Describe the subgroup and compare it to pattern of comorbidities: Performance at Tower of London
Determination of performance at the test of the Tower of London coupled with eye-tracking.
Tower of London: analysed variables are:
Number of problems solved (maximum duration is one minute) Failure if three successive problems are unsolved Types of error : systematic rule violation, back-and-forth Percentage of problems solved with the execution (minimal) number of moves. Duration for planification and execution
Measured: at inclusion
Calculate the classification concordance all pairs of dosage methods
Calculate the classification concordance (abnormal profile / normal profile) between all pairs of dosage methods (chromatography and 4 immuno-analysis based techniques)
Measured: at inclusion
Calculate 95% reference intervals with age as co-variable and separately for boys and girls.
The age-dependent dosing curves with the reference interval for free-T3, free-T4 and TSH will be obtained by the method described by Royston et al. (1998) and Wright \& Royston (1999).
Measured: at inclusion
Dose thyroid hormones and TSH levels with 4 different techniques of immuno-analysis
Free-T3 and free-T4 dosed on different immuno-analyses techniques will be correlated
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start21 Nov 2023
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit With Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080491
- Sponsor's protocol ID
- 21-HPNCL-04
- Acronym
- THYRADHD
- Status last verified
- Mar 2023
- First submitted
- 30 Sep 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Thyroid Profile in Children With Attention Deficit With Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT05080491
- Acronym / sponsor ID
- THYRADHD / 21-HPNCL-04
- Keywords
- ADHD, thyroid, free-T3, triiodothyronine, free-T4, thyroxine, TSH, chromatography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: The observational data of University Children's Hospitals of Nice, suggest that about a quarter of children and adolescents with ADHD may present with an abnormal thyroid profile.
Main objective: To confirm that a subsample of children and adolescents with ADHD present with an abnormal thyroid profile using the gold standard for free fraction of hormones : chromatography with mass spectrometry.
Secondary objective: To examine to what extent this categorization holds using classic immuno-analytic assays. To characterize clinically and from a neuropsychological point of view this subsample and compare it to the other participants.
Study duration and design: 30 months (24 months for inclusion and 6 months for data analyses) open-label, (category 2 : interventional research with minimal risks or constraints), multicentre, without treatment or placebo administration.
Expected outcomes: Ancillary studies will investigate genetic physiopathological mechanisms (polymorphisms of deiodase or transmembrane carriers of thyroid hormones) and link this profile to other biological markers proposed in the literature (low ferritinemia, higher oxidative stress, atopic comorbid disease). The clinical trajectory of this subgroup and the persistence of this abnormal thyroid profile in adulthood will be a relevant issue in the future.
Detailed description
Rationale: The internal observational data on 514 children and adolescents with ADHD suggest that 16-28% of them have an abnormal thyroid profile in immuno-analysis: normal free thyroid-stimulating hormone TSH and T4 but abnormally high free T3. Several pathophysiological hypotheses can be formulated, some of which relate to possible polymorphisms of the deiodase or transmembrane carriers of thyroid hormones, and also with other suspected biological markers of ADHD reported in the literature (low ferritin, atopic disease and oxidative stress). This abnormal thyroid profile may be an endophenotype of a subgroup of children and adolescents with ADHD. However, the reference technique for the determination of free fractions of hormones is chromatography with mass spectrometry and not immuno-analysis.
Main objective : To confirm by chromatography with mass spectrometry the existence of a subgroup of children and adolescents with ADHD with this abnormal thyroid profile.
Secondary objectives:
- Describe this subgroup by sex (male/female) and age (before 12 and after 12 years) clinically and neuropsychologically (Attention Network Task and Tower of London coupled with eye-tracking) and compare it with the rest of the sample.
- Dose thyroid hormones and TSH levels with 4 different techniques of immuno-analysis
- Calculate the classification concordance (abnormal profile / normal profile) between all pairs of dosage methods (chromatography and 4 immuno-analysis based techniques)
- Calculate 95% reference intervals for all assays and techniques throughout the sample.
Main evaluation criterion: free T3 greater than the 97.5 percentile of the reference interval in chromatography, free T4 between the 2.5 percentile and the 97.5 percentile with this same technique, and free TSH between the 2.5 percentile and the 97.5 percentile of the immuno-analytical reference interval.
Secondary evaluation criteria:
- Describe the subgroup and compare it to the rest of the sample:
- Number of criteria for inattention, hyperactivity-impulsivity and therefore clinical presentation of ADHD (Predominant Inattentive, Predominant Hyperactive-Impulsive, Combined)
- Scores for inattention, hyperactivity-impulsivity and their sum on the ADHD-Rating Scale and score on the Clinical Global Impression - Severity
- Pattern of comorbidities diagnosed with Kiddie-SADDS-PL, manual, ocular and pedestrian preference, presence of atopic disease
- Performance at the Attention Network Task and Test of the Tower of London coupled with eye-tracking
- Calculate the classification concordance all pairs of dosage methods (chromatography and 4 immuno-analysis based techniques): correlation, concordance indices 2x2 (for example, Cohen's kappa)
- Calculate 95% reference intervals with age as co-variable and separately for boys and girls.
Study duration: 30 months (24 months for inclusion and 6 months for data analyses) Study design: Open-label, cross-sectional (category 2 : interventional research with minimal risks or constraints), multicentre, no treatment or placebo administration.
Selection criteria:
- Inclusion criteria: Boys or girls aged 7 to 17 with ADHD (as per Diagnostic and Statistical Manual DSM-5 criteria).
- Criteria for Non-Inclusion:
- Known or concurrent diagnosis of Autism Spectrum Disorder, Schizophrenia or Psychotic Disorder (as determined by DSM-5), thyroid disease of any origin, genetic disease known to affect thyroid function.
- Any psychotropic treatment (for ADHD or others) in the month before inclusion or any treatment that may affect thyroid function
- Exclusion criteria: Withdrawal of informed consent by at least one of the child's parents or their legal representative.
Course of the study: The criteria for non-inclusion are checked, the diagnosis is confirmed using the Kiddie-SADS-PL before the child can be included. The patient's participation stops after the venous blood collection and the administration of two neuropsychological tests (Attention Network Task and Tower of London). The tubes are transported to the biochemistry laboratory of the CHU of Nice which prepares five aliquots (4 for assays in immuno-analysis including 2 on site, and one for assay in chromatography with mass spectrometry at the CHU of Toulouse).
Expected outcomes: The identification and clinical characterization of a subgroup of children and adolescents with ADHD with an abnormal thyroid profile will support the clinical diagnosis for these at least. Ancillary studies will investigate genetic physiopathological mechanisms (polymorphisms of deiodases or transmembrane carriers of thyroid hormones) and link this profile to other biological markers proposed in the literature (low ferritinemia, higher oxidative stress, atopic comorbid disease). The clinical trajectory of this subgroup and the persistence of this abnormal thyroid profile in adulthood will be relevant in the future
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Determination of thyroid profile and neuropsychological assessment | Experimental | Diagnostic Test: immuno analysis and neuropsychological tests |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Boys or girls aged by 7 and 17 years old included
- Diagnosed with ADHD according to DSM-5 criteria with either Inattentive predominant, Hyperactive-impulsive predominant or Combined presentations.
- Scoring at least 28 (maximum value 54) on the ADHD-RS total score that is the sum of 18 items each rated on a 0-3 scale.
- Scoring at least 4 (= Moderate) on the Clinical Global Impression - Severity scale
- Without any clinical symptom of either hypothyroidism or hyperthyroidism
Key exclusion criteria (10 listed)
- Known or concomitant diagnosis of Autism Spectrum Disorder according to DSM-5 criteria Known or concomitant diagnosis of Schizophrenia or Psychotic Disorder according to DSM-5 criteria Known or concomitant diagnosis of any thyroid disorder (hypothyroidism or hyperthyroidism) whatever the cause might be Known or concomitant diagnosis of any genetic condition affecting the thyroid function (e.g. Down syndrome)
- ADHD: methylphenidate, atomoxetine, dexamphetamine, lisdexamphetamine, guanfacine or clonidine.
- Any psychiatric disorder (antipsychotic, anxiolytics, antidepressant, etc.)
- Any compound containing thyroid hormones
- Anti-thyroid drugs: carbimazole, thiamazole, propylthiouracil and perchlorate
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 |
|---|---|---|
| immuno analysis and neuropsychological testsA venous blood sample will be taken for assay in immuno-analysis including and for assay in chromatography with mass spectrometry. Patients will participate in computer neuropsychological tests: . Venous blood collection and the administration : the tubes are transported to the biochemistry laboratory of the University Hospital Center of Nice (CHU Nice) which prepares five aliquots (4 for assays in immuno-analysis including 2 on site, and one for assay in chromatography with mass spectrometry. Administration of two neuropsychological tests on computer(Attention Network Task and Tower of London). | Diagnostic test | Determination of thyroid profile and neuropsychological assessment |
Primary outcome
Definition of an abnormal thyroid profile
Time frame: at inclusion
To confirm by chromatography with mass spectrometry the existence of a subgroup of children and adolescents with ADHD with this abnormal thyroid profile. Free T3 greater than the 97.5 percentile of the reference interval in chromatography, free T4 between the 2.5 percentile and the 97.5 percentile with this same technique, and free TSH between the 2.5 percentile and the 97.5 percentile of the immuno-analytical reference interval.
7 secondary outcomes
Describe the subgroup and compare it to pattern of comorbidities :ADHD Rating Scale
Time frame: at inclusion
Describe the subgroup and compare it to pattern of comorbidities :Kiddie-SADDS-PL
Time frame: at inclusion
Describe the subgroup and compare it to pattern of comorbidities: Performance at the Attention Network Task
Time frame: at inclusion
Describe the subgroup and compare it to pattern of comorbidities: Performance at Tower of London
Time frame: at inclusion
Calculate the classification concordance all pairs of dosage methods
Time frame: at inclusion
Calculate 95% reference intervals with age as co-variable and separately for boys and girls.
Time frame: at inclusion
Dose thyroid hormones and TSH levels with 4 different techniques of immuno-analysis
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Dominique Donzeau, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immuno analysis and neuropsychological tests in people with Attention Deficit With Hyperactivity Disorder, run by Fondation Lenval at 1 site in France.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hervé CACI,, MD PhD (4 92 03 03 92 ext. +33, caci.h@pediatrie-chulenval-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definition of an abnormal thyroid profile (time frame: at inclusion). 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 28 Feb 2024.