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Endocrine Disrupting Chemicals and Hormones in ADHD (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04970303
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Wang Liang-Jen, Chang Gung Memorial Hospital

Tracking Information
First Submitted Date July 1, 2021
First Posted Date July 21, 2021
Last Update Posted Date July 21, 2021
Actual Study Start Date July 12, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2021)
  • Growth hormone and thyroid function [ Time Frame: Baseline ]
    IGF-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
  • Growth hormone and thyroid function [ Time Frame: month 12 ]
    IGF-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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 11, 2021)
  • Children's growth-Height [ Time Frame: Baseline ]
    Height (cm)
  • Children's growth-Height [ Time Frame: month 12 ]
    Height (cm)
  • Children's growth-body weight [ Time Frame: Baseline ]
    body weight (kg)
  • Children's growth-body weight [ Time Frame: month 12 ]
    body weight (kg)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2021)
  • ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV) [ Time Frame: Baseline ]
    The 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.
  • ADHD clinical symptoms, The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV) [ Time Frame: month 12 ]
    The 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 120 patients with ADHD (aged between 6 and 16) and 60 age- and gender-matched control subjects.
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Methylphenidate
Retina or Concerta
Other Name: used Retina or Concerta
Study Groups/Cohorts
  • Case group
    investigator will recruit 60 patients with ADHD (aged between 6 and 16). 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.
    Intervention: Drug: Methylphenidate
  • Control group
    investigator will recruit 60 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 11, 2021)		 240
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04970303
Other Study ID Numbers 201900376A3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Wang Liang-Jen, Chang Gung Memorial Hospital
Original Responsible Party Same as current
Current Study Sponsor Chang Gung Memorial Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Liang-Jen Wang, MD, MPH, PhD Chang Gung Memorial Hospital, Kaohsiung, Taiwan
PRS Account Chang Gung Memorial Hospital
Verification Date July 2021