Micronutrients for ADHD

(FAST Trial)

Overseen By Hayleigh Ast, ND

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Neurological disorders, Cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a broad spectrum of vitamins and minerals (broad spectrum micronutrients) can help manage ADHD symptoms in children. Researchers aim to determine if families, particularly those identifying as Black or Hispanic, will participate and how they report changes in their child's behavior. The trial also collects blood and urine samples at home to study potential markers of ADHD. It may suit children aged 6-17 who have ADHD symptoms, can swallow pills, and come from families identifying as Black, Hispanic, or multicultural. As an unphased trial, this study offers families the chance to contribute to groundbreaking research that could enhance ADHD management.

Will I have to stop taking my current medications?

Yes, participants must be medication-free for 2 weeks before starting the trial.

What prior data suggests that these broad spectrum micronutrients are safe for children with ADHD?

Research has shown that broad spectrum micronutrients are generally safe for children with ADHD. In one study, children aged 6 to 12 took these supplements for eight weeks without major safety issues. In another study, parents noticed reduced anxiety in their children when they continued taking the micronutrients.

A different study examined the safety of these micronutrients over a longer period. The findings suggested they are safe for long-term use in managing mental health symptoms. Overall, these studies provide promising evidence for the safety of broad spectrum micronutrients in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using broad spectrum micronutrients for ADHD because this approach targets nutritional imbalances that might contribute to symptoms. Unlike standard treatments like stimulant medications, which directly alter brain chemistry, micronutrients aim to provide the body with essential vitamins and minerals, potentially addressing underlying deficiencies. This method could offer a more natural alternative with fewer side effects, appealing to individuals seeking non-pharmaceutical options.

What evidence suggests that broad spectrum micronutrients might be an effective treatment for ADHD?

Research has shown that broad-spectrum micronutrients, a variety of vitamins and minerals, can help reduce ADHD symptoms. In one study, children who took these micronutrients showed better attention and were less hyperactive. Another study found that these children also had fewer problems with attention and behavior. Most children found the treatment easy to follow, and the micronutrients were generally well tolerated. Overall, evidence suggests that these micronutrients could be helpful in managing ADHD symptoms in children. ^{4 5 6 7 8}

Who Is on the Research Team?

Jeanette Johnstone, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I can and will take 9-12 pills daily.

The child is identified as being Black/African American, Hispanic/Latina/o, or more than one race by their parent or caregiver.

Exclusion Criteria

I have a neurological disorder.

I have a mineral metabolism disorder.

I have a medical condition like cancer, kidney or liver disease, diabetes, or hyperthyroidism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the multinutrient treatment daily while collecting real-time parent-reported child behavior data and at-home biospecimens

8 weeks

Baseline, Week 4, Week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Broad Spectrum Micronutrients

Trial Overview 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.

How Is the Trial Designed?

Group I: Multinutrient Experimental Treatment 1 Intervention

All participants will take the active multinutrient treatment

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In the MADDY study, children with ADHD who received a multinutrient formula showed significant improvement in symptoms over 16 weeks, with response rates increasing from 53% to 66% for those who initially took the multinutrients, and from 23% to 64% for those who switched from placebo to multinutrients after 8 weeks.

The study found that longer treatment with multinutrients was associated with slightly greater height growth (2.3 cm vs. 1.8 cm) without an increase in adverse events, indicating a favorable safety profile for the multinutient intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension. Leung, BMY., Srikanth, P., Robinette, L., et al.[2023]

In a randomized clinical trial involving 135 nonmedicated children aged 6 to 12 with ADHD, 54% of those receiving micronutrients showed improvement in symptoms compared to only 18% in the placebo group, indicating significant efficacy of micronutrients in managing ADHD symptoms.

While both groups showed improvement in parent-rated ADHD symptoms, the difference was not statistically significant, but the micronutrient group experienced greater height growth and had no serious adverse events, suggesting a safe profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial. Johnstone, JM., Hatsu, I., Tost, G., et al.[2023]

In a 1-year follow-up of 93 children with ADHD, those who continued taking micronutrients showed significantly better overall improvement (84%) compared to those who switched to medications (50%) or discontinued treatment (21%).

Children on micronutrients also reported better outcomes in hyperactivity and anxiety, with no side effects, while those on medications experienced mood deterioration, highlighting the potential of micronutrients as a safe alternative for ADHD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mineral-Vitamin Treatment Associated with Remission in Attention-Deficit/Hyperactivity Disorder Symptoms and Related Problems: 1-Year Naturalistic Outcomes of a 10-Week Randomized Placebo-Controlled Trial. Darling, KA., Eggleston, MJF., Retallick-Brown, H., et al.[2020]

The authors acknowledge concerns regarding the use of broad-spectrum micronutrients, particularly manganese levels, in treating ADHD in children, indicating a need for caution.

They aim to clarify the rationale behind the specific doses of vitamins and minerals used in their studied formula, suggesting a focus on safety and appropriate dosing in ADHD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dr. Johnstone et al. Reply to Dr. Elmrayed. Johnstone, JM., Arnold, LE., Villagomez, A., et al.[2023]

A 6-month study involving 14 children with ADHD showed that a broad-spectrum micronutrient supplement significantly reduced ADHD symptoms and improved mood and overall functioning, with 71% of participants experiencing at least a 30% decrease in symptoms.

The treatment was found to be safe, with only mild and temporary side effects reported, and no safety issues identified through blood analyses, indicating that micronutrients could be a feasible option for managing ADHD in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Significant Symptom Reduction in Children with Attention-Deficit/Hyperactivity Disorder Treated with Micronutrients: An Open-Label Reversal Design Study. Gordon, HA., Rucklidge, JJ., Blampied, NM., et al.[2022]

In the 8-week MADDY trial involving 126 children aged 6-12, those taking broad-spectrum multinutrients showed a significantly higher response rate (54%) compared to those on placebo (18%) for ADHD symptoms with emotional dysregulation.

While overall diet quality did not affect treatment response, children with higher baseline vegetable intake experienced greater improvements from multinutrients, suggesting that specific dietary components may enhance the efficacy of ADHD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment response to supplemental nutrients for ADHD is independent of diet quality: the MADDY Study RCT. Robinette, LM., Hatsu, IE., Johnstone, JM., et al.[2023]

In a randomized controlled trial involving 93 medication-free children with ADHD, those receiving micronutrient treatment showed significant improvements in overall functioning and emotional regulation compared to a placebo group, with 47% reporting substantial improvement.

While the micronutrients did not significantly reduce core ADHD symptoms like hyperactivity, they were particularly beneficial for children with inattention and emotional dysregulation, and the treatment had a low rate of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin-mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo-controlled trial. Rucklidge, JJ., Eggleston, MJF., Johnstone, JM., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25056569/

Broad-spectrum micronutrient treatment for attention-deficit ... This review presents the published evidence on use of broad-spectrum micronutrients to treat ADHD symptoms.

2. nmi.health nmi.health/wp-content/uploads/2022/05/2-Julia-Rucklidge-Supplement-1-Research-compressed-1.pdf

Broad-Spectrum Micronutrient Treatment for Attention-Deficit Research review: the role of diet in the treatment of attention-deficit/hyperactivity disorder—an appraisal of the evidence on efficacy and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34303786/

Micronutrients for Attention-Deficit/Hyperactivity Disorder in ... Micronutrients showed greater height growth. Micronutrients were well tolerated, and the majority of participants adhered to the number of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03252522

Study Details | NCT03252522 | Micronutrients for Attention- ... This study examines a broad spectrum micronutrient treatment for children with ADHD. The goal is to broaden the scope of evidence-based treatments, ...

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2025.1624344/full

The impact of a multi-micronutrient nutritional formula ... Post-treatment analyses revealed greater reductions in attention deficit scores, hyperactivity/impulsivity scores, and oppositional symptoms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8782920/

Micronutrients for Attention-Deficit/Hyperactivity Disorder in ... A three-site 8-week placebo-controlled randomized clinical trial of micronutrients was conducted in unmedicated children ages 6-12 with ADHD and at least one ...

7. ohsu.edu ohsu.edu/sites/default/files/2019-09/An%20Observational%20Preliminary%20Study%20on%20the%20Safety%20of%20Long-Term%20Consumption%20of%20Micronutrients%20for%20the%20Treatment%20of%20Psychiatric%20Symptoms.pdf

An Observational Preliminary Study on the Safety of Long- ... The goal of this observational study was to investigate the safety of two commercially available broad-spectrum micronutrient formulas ( ...

8. frontiersin.org frontiersin.org/journals/child-and-adolescent-psychiatry/articles/10.3389/frcha.2023.1295635/full

Broad spectrum micronutrients: a potential key player to ... In the open label extended phase of the ADHD study (29), parents reported decreased levels of anxiety in the children who continued BSMs. An ...