Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT06133231

Conditions

Attention Deficit/Hyperactivity Disorder

Emotional Dysfunction

Irritable Mood

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants

Study Details

Brief summary:

Evaluate feasibility and acceptability of recruiting Black and Hispanic families for an open label clinical trial of multinutrients while collecting real-time parent-reported child behavior data and collecting at-home biospecimens to explore their potential as biomarkers, in a study of pediatric ADHD.

Conditions

Attention Deficit/Hyperactivity Disorder

Emotional Dysfunction

Irritable Mood

Study ID

NCT06133231

Start date

Jan 6, 2024

Status verified date

Jan, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children, ages 6-17 years at enrollment, with suspected or definite ADHD based on parent report in a majority of families that identify as Black or Hispanic or multicultural
  • Meet criteria on Child and Adolescent Symptom Inventory-5 (CASI-5) ADHD scale (6+ symptoms ≥ 2), occurring in >1 setting, plus one impairing irritability symptom (≥2) from Oppositional Defiant Disorder (ODD) or Disruptive Mood Dysregulation Disorder (DMDD) subscale
  • Able and willing to swallow up to 8 pills per day
  • Medication free for 2 weeks prior to baseline
  • Willing to use Tasso® OnDemand SST+ to collect blood at home and filter cards to provide urine samples
  • Able to communicate in English
  • Parent/care giver identifies child as Black/African American or Hispanic/Latina/o or more than one race (target 70-100%)

Exclusion Criteria:

  • Neurological disorders
  • Medical conditions (e.g. cancer, kidney or liver disease, diabetes, hyperthyroidism)
  • Psychiatric conditions requiring hospitalization
  • Allergy to any supplement ingredient
  • In people with a uterus: sexually active, pregnancy or suspected pregnancy
  • Abnormality of mineral metabolism

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Multinutrient

All participants will take the active multinutrient treatment

Interventions

Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants

Participants will take 2-4 capsules of EMP+ Advanced per day (max 8 capsules) for eight weeks.

Primary outcome measure

  • Feasibility measured by count of consumed multinutrients [ Time Frame: Week 4, Week 8 ]
  • Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale [ Time Frame: Week 8 ]

Central Contacts and Locations

Central contacts

Jeanette Johnstone, PhD

503-893-5873jojeanet@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jeanette Johnstone, PhD

503-893-5873jojeanet@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jan 16, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-01-16.