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Endocrine Disrupting Chemicals and Hormones in ADHD

The Roles of Endocrine Disrupting Chemicals, Growth Hormone and Thyroid Function in Attention-deficit/Hyperactivity Disorder

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04970303
Acronym
ADHD
Enrollment
240
Registered
2021-07-21
Start date
2019-07-12
Completion date
2021-12-31
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, endocrine disrupting chemicals, growth hormone, thyroid, methylphenidate

Brief summary

Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children and adolescents. Growth hormone and thyroid function are associated with both physical and neurocognitive development. Endocrine disrupting chemicals (EDCs) could disturb the normal function of endocrine systems, and further link to the pathophysiology of ADHD. In addition, whether methylphenidate for treating ADHD influences growth hormone and thyroid function of patients remains unclear.

Detailed description

Therefore, this study aims (1) to investigate the prospective role of EDCs, growth hormone and thyroid function in clinical manifestations of ADHD; and (2) to determine the influence of pharmacotherapy on growth hormone and thyroid function among patients with ADHD under a one-year methylphenidate treatment. Methods: In this two-year study, we will recruit 120 patients with ADHD (aged between 6 and 16) and 120 age- and gender-matched control subjects. Blood (10 ml) and urine (10 ml) will be obtained from each participant to analyze the levels of EDCs (Phthalates, Phenols and Parabens), growth hormone and thyroid function (TSH, T3, Free T4, T4, growth hormone, IGF-1and IGF-BP3). Behavior symptoms (ADHD-RS and SNAP-IV) and neuropsychological function (WISC, CPT and CATA) of each participant will be assessed. Patients with ADHD will receive treatment in a clinical practice and then will be followed up for 12 months. At the 12th month, the same procedures as those performed at the baseline will be replicated for patients with ADHD. This study will provide proof of the relationships of EDCs, endocrine systems and ADHD manifestations in clinical samples and further explain the biological pathogenesis of ADHD. In addition, this study will elucidate the influence of ADHD medications on growth hormone and thyroid function. Such information may become an important reference for future research and safety of pharmacotherapy for patients with ADHD.

Interventions

DRUGMethylphenidate

Retina or Concerta

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with ADHD aged between 6 and 16. * The patients were either newly diagnosed with ADHD or had an existing diagnosis but had not taken medication for ADHD during the previous 6 months or more.

Exclusion criteria

* Patients with a history of major physical or additional psychiatric diseases

Design outcomes

Primary

MeasureTime frameDescription
Growth hormone and thyroid functionBaselineIGF-1 (ng/mL), insulin-like growth factor-1; IGFBP-3 (ng/mL), IGF binding protein-3; TSH (µIU/mL), thyroid-stimulating hormone; T3 (ng/dL), triiodothyronine; T4 (µg/dL), thyroxine

Secondary

MeasureTime frameDescription
Children's growth-HeightBaselineHeight (cm)
Children's growth-body weightBaselinebody weight (kg)

Other

MeasureTime frameDescription
ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)BaselineThe SNAP-IV is a 26-item questionnaire used to evaluate ADHD symptoms and severity that needs to be completed by parents or teachers. The 26 items include 18 for ADHD symptoms (nine for inattention and nine for hyperactivity/impulsivity) and eight for oppositional defiant disorder (ODD) symptoms as defined by the DSM-IV. Each item is scored from 0-3 on a Likert scale. The total scores are ranged between 0 (min) to 78 (max), and higher scores mean a greater severity of ADHD.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026