Attention Deficit Hyperactivity DisorderPhase 1/2MADDYNCT03252522
Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study
A Phase 1/2 study testing Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants in people with Attention Deficit Hyperactivity Disorder, run by Oregon Health and Science University at 3 sites in 2 countries.
Trial summary
This proposed research will use randomized control trial (RCT) methodology and compare micronutrients with placebo in 135 children with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Apr 2018to 31 May 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
The Ohio State University
Columbus, Ohio, 43210
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Evaluating the Efficacy of Supplementation With Micronutrients for ADHD in Youth (MADDY) Study
This proposed research will use randomized control trial (RCT) methodology and compare micronutrients with placebo in 135 children with ADHD.
Read the detailed description
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants, Placebo
- Keywords
- ADHD, ODD, DMDD, Inattention, Impulsivity, Irritability, Anger, Micronutrients, Emotional Dysregulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidantsCombination product
Also called Daily Essential Nutrients (DEN)
60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
PlaceboDietary supplement
40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. Receives: Combination Product: Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants |
| Placebo | Placebo comparator | Capsules of inactive placebo. Receives: Dietary Supplement: Placebo |
| Open Label | Experimental | All participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients. Receives: Combination Product: Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants |
What is being measured
The primary outcome is the main question the study is designed to answer.
CASI-5 Parent-rated Composite Score
Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5). The CASI-5 is based on the DSM-5 symptom criteria. The subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict that will be combined into a total composite score; range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome.
Measured: Baseline and week 8
Clinical Global Impression (CGI) - Number of Participants Considered a Treatment Responder (Score of 1 or 2)
Second primary measure is the blinded clinician-rated CGI-Improvement (CGI-I) is a subscale of the CGI that rates overall improvement of symptoms based on all relevant data. Item range is 1-7 (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse); lower score is better. A treatment responder is defined as a participant who is rated a 1 or 2 on the CGI-I. The CGI-Severity (CGI-S) subscale will also be scored at baseline and week 8, with scores compared at the two time points. Item range is 1-7 (normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients); lower score is better; most participants will be a 4 or 5 at baseline.
Measured: Week 8
Secondary outcomes (11)
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
Albumin, Total Protein, Hemoglobin, Mean Cell Hgb in g/dL
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
AST, ALT, Alkaline in U/L
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
RBC Count in Cells/mcL
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
Mean Cell Volume in fL
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
Iron in ug/dL
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
WBC Count, Absolute Monocyte, Absolute Eosinophil, Platelet Count in Cells/mcL
Collect blood and urine samples at two time points. The samples are being collected per a request from the FDA for safety screening.
Measured: Baseline and Week 8
Clinical Global Impression (CGI)
Second primary measure is the blinded clinician-rated CGI-Improvement (CGI-I) is a subscale of the CGI that rates overall improvement of symptoms based on all relevant data. Item range is 1-7 (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse); lower score is better. A treatment responder is defined as a participant who is rated a 1 or 2 on the CGI-I. The CGI-Severity (CGI-S) subscale will also be scored at baseline and week 8, with scores compared at the two time points. Item range is 1-7 (normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients); lower score is better; most participants will be a 4 or 5 at baseline.
Measured: 16 weeks
CASI-5 Parent Report
Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5) subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict. The CASI-5 is based on the DSM-5 symptom criteria. Item range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome. The subscales for ADHD, ODD, and DMD will be composite scores.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start23 Apr 2018
- Primary completion10 Jul 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, University of Lethbridge, National University of Natural Medicine, Foundation for Excellence in Mental Health Care, The Waterloo Foundation
- Responsible party
- Principal investigator, Jeanette Johnstone, Oregon Health and Science University
- Investigators
- Jeanette Johnstone, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252522
- Sponsor's protocol ID
- 16870
- Acronym
- MADDY
- Status last verified
- Jan 2023
- First submitted
- 26 Jul 2017
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robinette LM, Hatsu IE, Wu CM, Adetona O, Bruton AM, Ast HK, Odei JB, Leung BMY, Johnstone JM, Ziouzenkova O. Association Between Trace Mineral Concentrations and Oxidative Stress in Children with ADHD Supplemented with Multinutrients. Biol Trace Elem Res. 2026 Jul;204(7):5081-5093. doi: 10.1007/s12011-026-05017-5. Epub 2026 Mar 3.
PubMed 41776068Robinette LM, Hatsu IE, Adetona O, Wu CM, Johnstone JM, Bruton AM, Ast HK, Odei JB, Ziouzenkova O, Leung BMY, Arnold LE. Multinutrients Decrease Oxidative Stress in Children With ADHD: Mediation/Moderation Analysis of Randomized Controlled Trial Data. J Atten Disord. 2025 Dec;29(14):1290-1306. doi: 10.1177/10870547251355998. Epub 2025 Aug 7.
PubMed 40772654Leung BMY, Srikanth P, Gracious B, Hatsu IE, Tost G, Conrad V, Johnstone JM, Arnold LE. Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study. Curr Med Res Opin. 2022 Sep;38(9):1595-1602. doi: 10.1080/03007995.2022.2096333. Epub 2022 Jul 11.
PubMed 35770861Johnstone JM, Hatsu I, Tost G, Srikanth P, Eiterman LP, Bruton AM, Ast HK, Robinette LM, Stern MM, Millington EG, Gracious BL, Hughes AJ, Leung BMY, Arnold LE. Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 May;61(5):647-661. doi: 10.1016/j.jaac.2021.07.005. Epub 2021 Jul 22.
PubMed 34303786Johnstone JM, Leung B, Gracious B, Perez L, Tost G, Savoy A, Hatsu I, Hughes A, Bruton A, Arnold LE. Rationale and design of an international randomized placebo-controlled trial of a 36-ingredient micronutrient supplement for children with ADHD and irritable mood: The Micronutrients for ADHD in Youth (MADDY) study. Contemp Clin Trials Commun. 2019 Oct 26;16:100478. doi: 10.1016/j.conctc.2019.100478. eCollection 2019 Dec.
PubMed 31763491
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Supplementation With Micronutrients for ADHD in Youth (MADDY) Study
- ClinicalTrials.gov ID
- NCT03252522
- Acronym / sponsor ID
- MADDY / 16870
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, ODD, DMDD, Inattention, Impulsivity, Irritability, Anger, Micronutrients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Ohio State University, University of Lethbridge, National University of Natural Medicine, Foundation for Excellence in Mental Health Care, The Waterloo Foundation
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Posted 9 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed research will use randomized control trial (RCT) methodology and compare micronutrients with placebo in 135 children with ADHD.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidantsCapsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules of inactive placebo. |
| Open Label | Experimental | Combination Product: Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidantsAll participants have the option to participate in an 8-week, naturalistic, open label follow-up in which the child will take the active micronutrient treatment; capsules of broad spectrum micronutrients. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidantsAlso: Daily Essential Nutrients (DEN)60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks | Combination product | Intervention, Open Label |
| Placebo40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks. | Dietary supplement | Placebo |
Primary outcome
CASI-5 Parent-rated Composite Score
Time frame: Baseline and week 8
Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5). The CASI-5 is based on the DSM-5 symptom criteria. The subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict that will be combined into a total composite score; range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome.
Clinical Global Impression (CGI) - Number of Participants Considered a Treatment Responder (Score of 1 or 2)
Time frame: Week 8
Second primary measure is the blinded clinician-rated CGI-Improvement (CGI-I) is a subscale of the CGI that rates overall improvement of symptoms based on all relevant data. Item range is 1-7 (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse); lower score is better. A treatment responder is defined as a participant who is rated a 1 or 2 on the CGI-I. The CGI-Severity (CGI-S) subscale will also be scored at baseline and week 8, with scores compared at the two time points. Item range is 1-7 (normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients); lower score is better; most participants will be a 4 or 5 at baseline.
11 secondary outcomes
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L
Time frame: Baseline and Week 8
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL
Time frame: Baseline and Week 8
Albumin, Total Protein, Hemoglobin, Mean Cell Hgb in g/dL
Time frame: Baseline and Week 8
AST, ALT, Alkaline in U/L
Time frame: Baseline and Week 8
RBC Count in Cells/mcL
Time frame: Baseline and Week 8
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
Time frame: Baseline and Week 8
Mean Cell Volume in fL
Time frame: Baseline and Week 8
Iron in ug/dL
Time frame: Baseline and Week 8
WBC Count, Absolute Monocyte, Absolute Eosinophil, Platelet Count in Cells/mcL
Time frame: Baseline and Week 8
Clinical Global Impression (CGI)
Time frame: 16 weeks
CASI-5 Parent Report
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41776068Robinette LM, Hatsu IE, Wu CM, Adetona O, Bruton AM, Ast HK, Odei JB, Leung BMY, Johnstone JM, Ziouzenkova O. Association Between Trace Mineral Concentrations and Oxidative Stress in Children with ADHD Supplemented with Multinutrients. Biol Trace Elem Res. 2026 Jul;204(7):5081-5093. doi: 10.1007/s12011-026-05017-5. Epub 2026 Mar 3.
- Derived from this study: PubMed 40772654Robinette LM, Hatsu IE, Adetona O, Wu CM, Johnstone JM, Bruton AM, Ast HK, Odei JB, Ziouzenkova O, Leung BMY, Arnold LE. Multinutrients Decrease Oxidative Stress in Children With ADHD: Mediation/Moderation Analysis of Randomized Controlled Trial Data. J Atten Disord. 2025 Dec;29(14):1290-1306. doi: 10.1177/10870547251355998. Epub 2025 Aug 7.
- Derived from this study: PubMed 35770861Leung BMY, Srikanth P, Gracious B, Hatsu IE, Tost G, Conrad V, Johnstone JM, Arnold LE. Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study. Curr Med Res Opin. 2022 Sep;38(9):1595-1602. doi: 10.1080/03007995.2022.2096333. Epub 2022 Jul 11.
- Derived from this study: PubMed 34303786Johnstone JM, Hatsu I, Tost G, Srikanth P, Eiterman LP, Bruton AM, Ast HK, Robinette LM, Stern MM, Millington EG, Gracious BL, Hughes AJ, Leung BMY, Arnold LE. Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 May;61(5):647-661. doi: 10.1016/j.jaac.2021.07.005. Epub 2021 Jul 22.
- Derived from this study: PubMed 31763491Johnstone JM, Leung B, Gracious B, Perez L, Tost G, Savoy A, Hatsu I, Hughes A, Bruton A, Arnold LE. Rationale and design of an international randomized placebo-controlled trial of a 36-ingredient micronutrient supplement for children with ADHD and irritable mood: The Micronutrients for ADHD in Youth (MADDY) study. Contemp Clin Trials Commun. 2019 Oct 26;16:100478. doi: 10.1016/j.conctc.2019.100478. eCollection 2019 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanette Johnstone principal investigator
Oregon Health and Science University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants in people with Attention Deficit Hyperactivity Disorder, run by Oregon Health and Science University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CASI-5 Parent-rated Composite Score (time frame: Baseline and week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252522, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.