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CompletedNCT03252522MADDYUpdated Feb 8, 2023Results posted

Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study

A Phase 1/2 interventional study of Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants and Placebo in Attention Deficit Hyperactivity Disorder, sponsored by Oregon Health and Science University. Completed at 3 sites in 2 countries. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Oregon Health and Science University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • ADHD
  • ODD
  • DMDD
  • Inattention
  • Impulsivity
  • Irritability
  • Anger
  • Micronutrients
  • Emotional Dysregulation
03

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
135 participants (actual)

Study arms

  • Experimental
    Intervention

    Capsules of broad spectrum micronutrients: a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.

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

  • Placebo comparator
    Placebo

    Capsules of inactive placebo.

    Dietary Supplement: Placebo

  • Experimental
    Open Label

    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.

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

Interventions

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

    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

    Also known as: Daily Essential Nutrients (DEN)

  • Dietary supplementPlacebo

    40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and week 8

  2. 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.

    Time frame: Week 8

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 8

  2. 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.

    Time frame: Baseline and Week 8

  3. 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.

    Time frame: Baseline and Week 8

  4. 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.

    Time frame: Baseline and Week 8

  5. 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.

    Time frame: Baseline and Week 8

  6. 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.

    Time frame: Baseline and Week 8

  7. 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.

    Time frame: Baseline and Week 8

  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.

    Time frame: Baseline and Week 8

  9. 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.

    Time frame: Baseline and Week 8

  10. 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.

    Time frame: 16 weeks

  11. 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.

    Time frame: Week 16

06

Results

Posted Feb 9, 2022

Participant flow

Phase 1: Intervention & Placebo
Participant flow — Phase 1: Intervention & Placebo
MilestoneInterventionPlaceboOpen Label
Started78570
Completed69540
Not completed930
Withdrew: Adverse event310
Withdrew: Unable to swallow pills410
Withdrew: Commenced stimulant medication110
Withdrew: Protocol violation100
Phase 2: Open Label
Participant flow — Phase 2: Open Label
MilestoneInterventionPlaceboOpen Label
Started00123
Completed0099
Not completed0024
Withdrew: Commenced stimulant medication003
Withdrew: Lack of efficacy003
Withdrew: Adverse event002
Withdrew: Lost to follow-up0016

Outcome measures

PrimaryCASI-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.

Time frame:
Baseline and week 8
Reported as:
Mean · score on a scale
CASI-5 Parent-rated Composite Score
score on a scaleInterventionPlacebo
Baseline1.49 ± 0.081.52 ± 0.08
Week 81.18 ± 0.081.23 ± 0.08
PrimaryClinical 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.

Time frame:
Week 8
Reported as:
Count of participants · Participants
Clinical Global Impression (CGI) - Number of Participants Considered a Treatment Responder (Score of 1 or 2)
ParticipantsInterventionPlacebo
Clinical Global Impression (CGI) - Number of Participants Considered a Treatment Responder (Score of 1 or 2)3810
SecondarySodium, 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · mmol/L
Sodium, Potassium, Chloride, Carbon Dioxide, and Anion Gap in mmol/L
mmol/LIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
Sodium139.13 ± 0.34139.16 ± 0.34139.28 ± 0.36139.42 ± 0.37
Potassium4.1 ± 0.104.06 ± 0.104.09 ± 0.104.0 ± 0.10
Chloride105.07 ± 0.96104.81 ± 0.97104.88 ± 0.97105.28 ± 0.98
Carbon dioxide25.62 ± 0.2125.64 ± 0.2225.97 ± 0.2425.86 ± 0.25
Anion gap10.30 ± 2.8310.64 ± 2.8310.31 ± 2.8310.15 ± 2.84
SecondaryCalcium, 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · mg/dL
Calcium, Blood Urea Nitrogen, Creatinine, Glucose, Bilirubin Total in mg/dL
mg/dLIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
Calcium9.47 ± 0.209.49 ± 0.209.47 ± 0.209.40 ± 0.20
Blood urea nitrogen (BUN)12.48 ± 0.4113.17 ± 0.4212.56 ± 0.4612.13 ± 0.48
Creatinine0.46 ± 0.010.49 ± 0.010.46 ± 0.010.46 ± 0.01
Glucose82.15 ± 2.3683.03 ± 2.3979.45 ± 2.4480.0 ± 2.46
Bilirubin total0.47 ± 0.030.45 ± 0.030.49 ± 0.030.46 ± 0.03
SecondaryAlbumin, 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · g/dL
Albumin, Total Protein, Hemoglobin, Mean Cell Hgb in g/dL
g/dLIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
Albumin4.34 ± 0.174.34 ± 0.174.29 ± 0.174.28 ± 0.17
Total protein7.15 ± 0.638.45 ± 0.657.07 ± 0.737.06 ± 0.76
Hemoglobin12.99 ± 0.1712.96 ± 0.1712.99 ± 0.1812.91 ± 0.18
Mean cell Hgb concentration33.82 ± 0.1333.59 ± 0.1333.75 ± 0.1533.47 ± 0.15
SecondaryAST, 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · U/L
AST, ALT, Alkaline in U/L
U/LIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
AST23.58 ± 1.2627.28 ± 1.2825.72 ± 1.4222.79 ± 1.46
ALT18.67 ± 3.2526.00 ± 3.2720.40 ± 3.3718.09 ± 3.41
Alkaline phosphatase255 ± 8.10241.33 ± 8.15252.21 ± 9.29257.93 ± 9.41
SecondaryRBC 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · cells/mcL
RBC Count in Cells/mcL
cells/mcLIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
RBC Count in Cells/mcL4,650,000 ± 0.084,650,000 ± 0.084,600,000 ± 0.084,600,000 ± 0.09
SecondaryHematocrit, 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · percent
Hematocrit, RBC Distribution, Immature Grans, Lymphocyte, Monocyte, Eosinophil in Percent
percentIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
Hematocrit38.40 ± 0.5238.60 ± 0.5238.50 ± 0.5538.60 ± 0.55
RBC distribution25.03 ± 8.7625.17 ± 8.7625.29 ± 8.7625.02 ± 8.76
Immature grans0.20 ± 0.020.18 ± 0.020.24 ± 0.020.19 ± 0.03
Lymphocyte43.63 ± 1.6543.53 ± 1.6640.25 ± 1.8040.65 ± 1.84
Monocyte8.03 ± 0.348.29 ± 0.347.78 ± 0.388.35 ± 0.38
Eosinophil3.82 ± 0.634.03 ± 0.646.49 ± 0.735.71 ± 0.75
SecondaryMean 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · fL
Mean Cell Volume in fL
fLIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
Mean Cell Volume in fL82.70 ± 0.4483.00 ± 0.4583.74 ± 0.4983.85 ± 0.50
SecondaryIron 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · ug/dL
Iron in ug/dL
ug/dLIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
Iron in ug/dL99.1 ± 4.6590.7 ± 4.69100.5 ± 5.3595.5 ± 5.49
SecondaryWBC 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.

Time frame:
Baseline and Week 8
Reported as:
Mean · cells/mcL
WBC Count, Absolute Monocyte, Absolute Eosinophil, Platelet Count in Cells/mcL
cells/mcLIntervention (Baseline)Intervention (Week 8)Placebo (Baseline)Placebo (Week 8)
WBC count5,710 ± 0.225,730 ± 0.236,080 ± 0.255,990 ± 0.26
Absolute monocyte460 ± 0.02470 ± 0.02460 ± 0.02480 ± 0.02
Absolute eosinophil210 ± 0.04230 ± 0.04390 ± 0.04340 ± 0.05
Platelet count289,970 ± 7.54289,320 ± 7.57290,160 ± 8.62295,900 ± 8.75
SecondaryClinical 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.

Time frame:
16 weeks
Reported as:
Count of participants · Participants
Clinical Global Impression (CGI)
ParticipantsOpen Label (Week 8 to Week 16)
Clinical Global Impression (CGI)103
SecondaryCASI-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.

Time frame:
Week 16
Reported as:
Mean · score on a scale
CASI-5 Parent Report
score on a scaleOpen Label (Week 8 to Week 16)
Week 121.14 ± 0.04
Week 160.99 ± 0.05

Adverse events

Collected over Baseline, week 1, week 4, week 8 and week 16. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention0/69 (0%)0/69 (0%)22/69 (31.9%)
Placebo0/54 (0%)0/54 (0%)24/54 (44.4%)
Open Label0/99 (0%)0/99 (0%)26/99 (26.3%)
Most frequent other events
Showing 10 of 28
Most frequent other events
EventInterventionPlaceboOpen Label
GI symptomsGastrointestinal disorders17/698/549/99
OtherGeneral disorders5/695/542/99
Trouble falling asleepGeneral disorders4/691/540/99
Less hungryMetabolism and nutrition disorders4/691/544/99
Angry or hostilePsychiatric disorders3/691/542/99
Anxious, tense, or uptightPsychiatric disorders3/691/542/99
Lack of self-control/ impulsivePsychiatric disorders3/692/541/99
Can't sit or stand stillPsychiatric disorders3/691/540/99
HeadacheNervous system disorders1/692/540/99
Sad or low moodPsychiatric disorders2/690/543/99

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)InterventionPlaceboTotal
<=18 years7857135
Between 18 and 65 years000
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)InterventionPlaceboTotal
Female212243
Male573592
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)InterventionPlaceboTotal
Ethnicity — Not Hispanic or Latino454085
Ethnicity — Hispanic or Latino718
Ethnicity — Other437
Ethnicity — Unknown/Did Not Report221335
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)InterventionPlaceboTotal
Race — Asian303
Race — African American/Black134
Race — White6045105
Race — Other347
Race — Unknown/Not Reported11516
Region of Enrollment
Region of Enrollment(participants)InterventionPlaceboTotal
Canada211738
United States503888
07

Study locations

3 sites
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • University of Lethbridge
    Lethbridge, Alberta AB T1K 6T5, Canada
08

References and documents

Publications

  • Leung 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 35770861 ↗
  • Johnstone 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. Erratum In: J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):1066. doi: 10.1016/j.jaac.2022.04.021. J Am Acad Child Adolesc Psychiatry. 2023 May;62(5):607. doi: 10.1016/j.jaac.2022.12.009. J Am Acad Child Adolesc Psychiatry. 2023 Nov;62(11):1276. doi: 10.1016/j.jaac.2023.07.995. PubMed 34303786 ↗
  • Johnstone 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 documents

  • Protocol and statistical analysis plan · Feb 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03252522
Lead sponsor
Oregon Health and Science University
Collaborators
Ohio State University, University of Lethbridge, National University of Natural Medicine, Foundation for Excellence in Mental Health Care, The Waterloo Foundation
Responsible party
Jeanette Johnstone (Principal Investigator, Oregon Health and Science University) — Principal investigator
First posted
Aug 17, 2017
Start date
Apr 23, 2018
Primary completion
Jul 10, 2020
Completion
May 31, 2021
Results posted
Feb 9, 2022
Last update
Feb 8, 2023

Study contacts

Jeanette Johnstone
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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