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

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Broad Spectrum Micronutrients for ADHD?

Research shows that children with ADHD who took broad-spectrum micronutrients had significant improvements in symptoms compared to those who took a placebo. In one study, 54% of children taking the micronutrients showed improvement, compared to only 18% in the placebo group. Additionally, those who continued the micronutrient treatment over a year maintained their improvements without side effects. ^{1 2 3 4 5}

Is the broad spectrum micronutrient treatment safe for children with ADHD?

Studies on broad spectrum micronutrients for children with ADHD have evaluated safety, noting some adverse events (unwanted effects) but generally finding the treatment to be safe over periods of 8 to 16 weeks. ^{1 2 3 5 6}

How does the broad spectrum micronutrient treatment for ADHD differ from other treatments?

The broad spectrum micronutrient treatment for ADHD is unique because it uses a combination of 36 vitamins and minerals to improve symptoms, unlike standard medications that often focus on altering brain chemicals. This approach has shown benefits in emotional regulation and overall psychological functioning without the side effects commonly associated with psychiatric medications. ^{2 3 4 5 7}

Research Team

Jeanette Johnstone, PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment response to supplemental nutrients for ADHD is independent of diet quality: the MADDY Study RCT. [2023]

2. United States 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Vitamin-mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo-controlled trial. [2021]

4. United States 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. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Dr. Johnstone et al. Reply to Dr. Elmrayed. [2023]