Clinical trial NCT04970303: Endocrine Disrupting Chemicals and Hormones in ADHD
Official title: The Roles of Endocrine Disrupting Chemicals, Growth Hormone and Thyroid Function in Attention-deficit/Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
endocrine disrupting chemicals
growth hormone
thyroid
methylphenidate
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 patients with ADHD (aged between 6 and 16) and 60 age- and gender-matched control subjects.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Growth hormone and thyroid function
timeFrame: Baseline
measure: Growth hormone and thyroid function
timeFrame: month 12
Secondary outcomes:
measure: Children's growth-Height
timeFrame: Baseline
measure: Children's growth-Height
timeFrame: month 12
measure: Children's growth-body weight
timeFrame: Baseline
measure: Children's growth-body weight
timeFrame: month 12
Other outcomes:
measure: ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)
timeFrame: Baseline
measure: ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)
timeFrame: month 12
Locations:
city: Kaohsiung
country: Taiwan
facility: Liang-Jen Wang
Study officials:
affiliation: Chang Gung Memorial Hospital, Kaohsiung, Taiwan
name: Liang-Jen Wang, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: