Micronutrients for Attention-Deficit Hyperactivity Disord... | NCT03252522

Status Module

Name	Class
Ohio State University	OTHER
University of Lethbridge	OTHER
National University of Natural Medicine	OTHER
Foundation for Excellence in Mental Health Care

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.	Combination Product: Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants
Placebo	Placebo Comparator	Capsules of inactive placebo.	Dietary Supplement: Placebo
Open Label	Experimental	All participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients.	Combination Product: Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants	Combination Product	60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CASI-5 Parent-rated Composite Score	Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5). The CASI-5 is based on the DSM-5 symptom criteria. The subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict that will be combined into a total composite score; range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome.	Baseline and week 8
Clinical Global Impression (CGI) - Number of Participants Considered a Treatment Responder (Score of 1 or 2)	Second primary measure is the blinded clinician-rated CGI-Improvement (CGI-I) is a subscale of the CGI that rates overall improvement of symptoms based on all relevant data. Item range is 1-7 (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse); lower score is better. A treatment responder is defined as a participant who is rated a 1 or 2 on the CGI-I. The CGI-Severity (CGI-S) subscale will also be scored at baseline and week 8, with scores compared at the two time points. Item range is 1-7 (normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients); lower score is better; most participants will be a 4 or 5 at baseline.	Week 8

Secondary Outcomes

Measure	Description	Time Frame
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L	Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.	Baseline and Week 8
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age inclusive of and between 6 and 12 years at the time of enrollment.
Verbally willing to swallowing a maximum of 9-12 capsules/day with food, attend all study appointments and complete questionnaires.
Meet criteria for ADHD as assessed by the clinical cut-off (6+ questions scored as 2's or 3's, "often," or "very often") on the Category A: ADHD questions from on the Child & Adolescent Symptom Inventory-5 (CASI-5) with at least several symptoms present in more than one setting, based on the Diagnostic and Statistical Manual (DSM) 5 symptom criteria, including significant impairment in functioning socially and/or academically.
Demonstrate at least one symptom of irritability or anger as assessed by a score of 2 or 3 on one question from Category B or Rz from the CASI-5.
Be medication-free, or washout with medical supervision to be provided by the child's pediatrician or primary care physician, reliant on the parent/guardian to work with that physician, for at least two weeks prior to in-person study assessment. Washout will be recorded as occurring on the date reported by the parent/guardian, with a faxed copy of the progress note, visit summary or signed letter from participant's doctor.

Exclusion Criteria:

Neurological disorder involving brain or other central function (e.g., history of or suspected intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder, active suicidal ideation, or psychosis), based on parent/guardian self-report of child's condition and responses to category M on the CASI-5 subscale.
Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II.
Known allergy to any ingredients of the intervention.
Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis).
Taking any other medication with primarily central nervous system activity, including stimulants, within the last two weeks prior to in-person assessment; participants must be off these medications for a minimum of two weeks prior to the screening.
Severe separation anxiety that would preclude separating from parent/guardian to answer study questionnaires.
Any disability that would interfere with participant answering questions verbally.
Non-English speaking.
Pregnancy or sexually active at baseline. Exclusion criteria 1-6 and 9, will be based on parent/guardian self-report of child's condition. If the parent/guardian reports medical exclusion criteria, or concerns about eligibility, data provided by parent/guardian will be confirmed by review of medical records with release of information signed by parent/guardian. Potential participant may be reviewed in-person by a study physician in the case of any concerns about participation.

Name	Affiliation	Role
Jeanette Johnstone	Oregon Health and Science University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University		Columbus	Ohio	43210	United States
Oregon Health & Science University

PubMed Identifier	Type	Citation	Retractions
41776068	Derived	Robinette LM, Hatsu IE, Wu CM, Adetona O, Bruton AM, Ast HK, Odei JB, Leung BMY, Johnstone JM, Ziouzenkova O. Association Between Trace Mineral Concentrations and Oxidative Stress in Children with ADHD Supplemented with Multinutrients. Biol Trace Elem Res. 2026 Mar 3. doi: 10.1007/s12011-026-05017-5. Online ahead of print.
40772654

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Intervention	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 23, 2021

Arm/Group Information

ID	Title	Description
BG000	Intervention	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
BG001	Placebo	Capsules of inactive placebo. Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0001.49± 0.08 OG0011.52± 0.08

Week 8

Title	Measurements
	OG000

Primary

Clinical Global Impression (CGI) - Number of Participants Considered a Treatment Responder (Score of 1 or 2)

Second primary measure is the blinded clinician-rated CGI-Improvement (CGI-I) is a subscale of the CGI that rates overall improvement of symptoms based on all relevant data. Item range is 1-7 (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse); lower score is better. A treatment responder is defined as a participant who is rated a 1 or 2 on the CGI-I. The CGI-Severity (CGI-S) subscale will also be scored at baseline and week 8, with scores compared at the two time points. Item range is 1-7 (normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients); lower score is better; most participants will be a 4 or 5 at baseline.

Participants considered in the ITT analysis

Posted

Count of Participants

Participants

Week 8

ID	Title	Description
OG000	Intervention	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Placebo

Secondary

Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Only participants in the US sites provided blood and urine samples. Canadian participants were not required by Health Canada to collect safety blood or urine samples, hence the lower number of participants.

Posted

Mean

Standard Error

mmol/L

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Posted

Mean

Standard Error

mg/dL

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

Albumin, Total Protein, Hemoglobin, Mean Cell Hgb in g/dL

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Posted

Mean

Standard Error

g/dL

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

AST, ALT, Alkaline in U/L

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Posted

Mean

Standard Error

U/L

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

RBC Count in Cells/mcL

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Posted

Mean

Standard Error

cells/mcL

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Posted

Mean

Standard Error

percent

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

Mean Cell Volume in fL

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Posted

Mean

Standard Error

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

Iron in ug/dL

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Posted

Mean

Standard Error

ug/dL

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

WBC Count, Absolute Monocyte, Absolute Eosinophil, Platelet Count in Cells/mcL

Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.

Posted

Mean

Standard Error

cells/mcL

Baseline and Week 8

ID	Title	Description
OG000	Intervention (Baseline)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
OG001	Intervention (Week 8)	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

Secondary

Clinical Global Impression (CGI)

Posted

Count of Participants

Participants

16 weeks

ID	Title	Description
OG000	Open Label (Week 8 to Week 16)	All children knowingly received the active intervention

Units	Counts
Participants	OG000

Secondary

CASI-5 Parent Report

Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5) subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict. The CASI-5 is based on the DSM-5 symptom criteria. Item range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome. The subscales for ADHD, ODD, and DMD will be composite scores.

Posted

Mean

Standard Error

score on a scale

Week 16

ID	Title	Description
OG000	Open Label (Week 8 to Week 16)	All children knowingly received the active intervention

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intervention	Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks	69	69	22	69
EG001	Placebo	Capsules of inactive placebo. Placebo: 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.	54	54	24	54
EG002	Open Label	All participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients. Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants: 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks	99	99	26	99

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Irritability	Psychiatric disorders	Systematic Assessment		EG0001 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Angry or hostile	Psychiatric disorders	Systematic Assessment		EG0003 affected69 at risk EG0011 affected54 at risk EG0022 affected99 at risk
Sad or low mood	Psychiatric disorders	Systematic Assessment		EG0002 affected69 at risk EG0010 affected54 at risk EG0023 affected99 at risk
Lack of interest	Psychiatric disorders	Systematic Assessment		EG0002 affected69 at risk EG0010 affected54 at risk EG0021 affected99 at risk
Mood swings	Psychiatric disorders	Systematic Assessment		EG0002 affected69 at risk EG0011 affected54 at risk EG0022 affected99 at risk
Anxious, tense, or uptight	Psychiatric disorders	Systematic Assessment		EG0003 affected69 at risk EG0011 affected54 at risk EG0022 affected99 at risk
Lack of self-control/ impulsive	Psychiatric disorders	Systematic Assessment		EG0003 affected69 at risk EG0012 affected54 at risk EG0021 affected99 at risk
Trouble paying attention or concentrating	Psychiatric disorders	Systematic Assessment		EG0002 affected69 at risk EG0010 affected54 at risk EG0020 affected99 at risk
Racing thoughts	Psychiatric disorders	Systematic Assessment		EG0001 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Can't sit or stand still	Psychiatric disorders	Systematic Assessment		EG0003 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Tired/fatigued	General disorders	Systematic Assessment		EG0002 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Trouble falling asleep	General disorders	Systematic Assessment		EG0004 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Tried to hurt himself/ herself	Psychiatric disorders	Systematic Assessment		EG0001 affected69 at risk EG0010 affected54 at risk EG0021 affected99 at risk
Hurt someone or something	Psychiatric disorders	Systematic Assessment		EG0001 affected69 at risk EG0011 affected54 at risk EG0021 affected99 at risk
Less hungry	Metabolism and nutrition disorders	Systematic Assessment		EG0004 affected69 at risk EG0011 affected54 at risk EG0024 affected99 at risk
Lost weight	Metabolism and nutrition disorders	Systematic Assessment		EG0000 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Dry mouth	Metabolism and nutrition disorders	Systematic Assessment		EG0001 affected69 at risk EG0010 affected54 at risk EG0020 affected99 at risk
Gained weight	Metabolism and nutrition disorders	Systematic Assessment		EG0000 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Muscle shaking, stiffness, or cramps	Nervous system disorders	Systematic Assessment		EG0000 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Tics	Nervous system disorders	Systematic Assessment		EG0000 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
Unusually good mood or super happy	Psychiatric disorders	Systematic Assessment		EG0001 affected69 at risk EG0011 affected54 at risk EG0022 affected99 at risk
Skin rash or irritation	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 affected69 at risk EG0010 affected54 at risk EG0021 affected99 at risk
Heart racing or skipping beats	Cardiac disorders	Systematic Assessment		EG0000 affected69 at risk EG0011 affected54 at risk EG0020 affected99 at risk
GI symptoms	Gastrointestinal disorders	Systematic Assessment	GI symptoms are a combination of discrete participants experiencing stomach ache or cramps, nausea/sick to stomach, throwing up/vomiting, and diarrhea.	EG00017 affected69 at risk EG0018 affected54 at risk EG0029 affected99 at risk
Headache	Nervous system disorders	Systematic Assessment		EG0001 affected69 at risk EG0012 affected54 at risk EG0020 affected99 at risk
Other	General disorders	Systematic Assessment		EG0005 affected69 at risk EG0015 affected54 at risk EG0022 affected99 at risk
Chest Pain	General disorders	Systematic Assessment		EG0000 affected69 at risk EG0010 affected54 at risk EG0021 affected99 at risk
Dizzy or light-headed	General disorders	Systematic Assessment		EG0000 affected69 at risk EG0010 affected54 at risk EG0021 affected99 at risk

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D007175	Impulsive Behavior

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D001519	Behavior

ID	Term
D008903	Minerals
D000596	Amino Acids
D000975	Antioxidants

ID	Term
D007287	Inorganic Chemicals
D000602	Amino Acids, Peptides, and Proteins
D001685	Biological Factors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D020011	Protective Agents
D045505	Physiological Effects of Drugs
D020313	Specialty Uses of Chemicals