Evaluating the Efficacy of Supplementation With Micronutrients in ADHD Youth

This study examines a broad spectrum micronutrient treatment for children with ADHD. The goal
is to broaden the scope of evidence-based treatments, and to address the public desire for
non-pharmacological treatment options. This study will use a randomized controlled trial
design, comparing micronutrients with placebo in 135 children, ages 6-12, with ADHD plus
irritability or anger based on parent-report of symptoms. The study will also collect
biological samples (saliva, stool, urine, hair, and blood) from the children to examine
physiological mechanisms of micronutrient effects. If the micronutrient treatment
successfully diminishes symptoms, the clinical implication is to offer this as a legitimate
non-pharmacological alternative to stimulant medication.

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.