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Dietary Supplement

Micronutrients for ADHD

N/A

Waitlist Available

Led By Jeanette Johnstone, PhD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children, ages 6-12 years at enrollment, with suspected or definite ADHD based on parent report in a family that identifies as Black or Hispanic

Able and willing to swallow 9-12 pills per day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4, week 8

Awards & highlights

Study Summary

This trial studies if micronutrients help with ADHD in Black & Hispanic families. It will collect data & biospecimens to explore potential biomarkers.

Who is the study for?

This trial is for Black or Hispanic children aged 6-12 with ADHD and irritability, who can swallow multiple pills daily. They must not be on medication for two weeks prior to the study, be able to provide at-home blood and urine samples, and communicate in English. It excludes those with neurological disorders, serious medical conditions like cancer or diabetes, recent psychiatric hospitalization, allergies to supplement ingredients, or in females—sexual activity or pregnancy.Check my eligibility

What is being tested?

The study tests a blend of vitamins, minerals, amino acids, and antioxidants called Broad Spectrum Micronutrients on pediatric ADHD. It aims to assess how feasible it is to recruit diverse families into the trial while gathering behavior data from parents in real-time and exploring new biomarkers through at-home biospecimen collection.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to individual sensitivities or intolerances to any of the numerous supplement ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a Black or Hispanic child aged 6-12 with ADHD.

Select...

I can and will take 9-12 pills daily.

Select...

I haven't taken any medications for the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4x on one day only to reflect 24-hour urine collection - baseline, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4x on one day only to reflect 24-hour urine collection - baseline, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4x on one day only to reflect 24-hour urine collection - baseline, week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale

Feasibility measured by count of consumed micronutrients

Secondary outcome measures

Acceptability of Capillary Blood Collection

Acceptability of Collecting 24-hour Urine

Acceptability of Collecting Real-Time EMA Parent Target Problem (PTP)

+10 more

Side effects data

From 2021 Phase 1 & 2 trial • 135 Patients • NCT03252522

25%

GI symptoms

Other

Trouble falling asleep

Less hungry

Anxious, tense, or uptight

Angry or hostile

Lack of self-control/ impulsive

Can't sit or stand still

Sad or low mood

Mood swings

Tired/fatigued

Trouble paying attention or concentrating

Lack of interest

Unusually good mood or super happy

Irritability

Dry mouth

Hurt someone or something

Skin rash or irritation

Tried to hurt himself/ herself

Headache

Racing thoughts

100%

80%

60%

40%

20%

Study treatment Arm

Intervention

Placebo

Open Label

Trial Design

1Treatment groups

Experimental Treatment

Group I: MicronutrientExperimental Treatment1 Intervention

All participants will take the active micronutrient treatment; capsules of broad spectrum micronutrients.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants

2018

Completed Phase 2

~140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

973 Previous Clinical Trials

6,845,999 Total Patients Enrolled

Jeanette Johnstone, PhDPrincipal InvestigatorOregon Health and Science University

2 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participants in this research effort?

"The clinical trial, which was initially posted on May 1st 2024 and last revised on November 10th 2023 is not currently accepting participants. Nevertheless, there are 195 other trials actively recruiting patients at this moment in time."

Answered by AI

Could I potentially participate in this experiment?

"The ideal candidate for this research trial has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and is between the ages of 6 and 12. Up to 30 participants are being sought out for enrollment at this time."

Answered by AI

Is enrollment open for adults aged 20 and older in this research project?

"As per the study's eligibility criteria, only individuals between 6 and 12 years old are qualified to apply. Furthermore, there are 135 studies available for minors while 39 trials can be accessed by those who have exceeded 65 years of age."

Answered by AI

What objectives are being pursued by this research project?

"The key purpose of this study, assessed over Week 4 and 8, is to gauge how participants respond to the Abbreviated Acceptability Rating Profile (AARP-7) comprised of questions scored on a 6-point Likert scale. Other secondary objectives include assessing approval ratings for capillary blood collection via Tasso device as well as collecting 24 hour urine samples using an at-home method with qualitative feedback being collected. Finally, Clinical Global Impression Severity scores will be used to track changes in patients' states pre and post treatment; these are rated from 1 - 7 where lower numbers denote better overall health."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Research With Diverse Families

Jeanette Johnstone 2024. "Optimizing Research With Diverse Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06133231.