Evidence map›Paper›PMID 37291464›Full record

Trial reportEuropean child & adolescent psychiatry2024

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

Brenda M Y Leung, Priya Srikanth, Lisa Robinette, Alisha M Bruton, Gabriella Tost, Irene Hatsu, L Eugene Arnold, Jeanette M Johnstone

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in European child & adolescent psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Serotonin dysfunction in ADHD.Journal of neurodevelopmental disorders · 2025
    Review
  10. Annual Research Review: Micronutrients and their role in the treatment of paediatric mental illness.Journal of child psychology and psychiatry, and allied disciplines · 2025
    Review
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Brenda M Y LeungFaculty of Health Sciences, University of Lethbridge, 4401 University Drive, Lethbridge, AB, Canada. brenda.leung@uleth.ca.ORCID http://orcid.org/0000-0002-4699-8086
Priya SrikanthOregon Health & Science University-Portland State University School of Public Health, Portland, OR, USA.ORCID http://orcid.org/0000-0002-0906-6757
Lisa RobinetteDepartment of Human Sciences, The Ohio State University, Columbus, OH, USA.ORCID http://orcid.org/0000-0002-9314-9538
Alisha M BrutonDepartment of Psychiatry, Oregon Health & Science University, Portland, OR, USA.ORCID http://orcid.org/0000-0002-5929-3149
Gabriella TostDepartment of Psychiatry, Oregon Health & Science University, Portland, OR, USA.ORCID http://orcid.org/0000-0003-1464-4918
Irene HatsuDepartment of Human Sciences, The Ohio State University, Columbus, OH, USA.ORCID http://orcid.org/0000-0003-0501-9088
L Eugene ArnoldDepartment of Psychiatry & Behavioral Health, The Ohio State University, Columbus, OH, USA.ORCID http://orcid.org/0000-0002-0886-0692
Jeanette M JohnstoneDepartment of Psychiatry, Oregon Health & Science University, Portland, OR, USA.ORCID http://orcid.org/0000-0003-3947-5540

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
The OSU Center for Clinical and Translational Science: Advancing Today's Discoveries to Improve HealthUL1TR002733 · NCATS · OHIO STATE UNIVERSITY · PI RINGEL, MATTHEW D · 2018 to 2022
$28.9M
Oregon Clinical and Translational Research InstituteUL1TR000128 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI ELLISON, DAVID H · 2012 to 2015
$28.7M
CAM Research Training in Neuroscience &StressT32AT002688 · NCCIH · OREGON HEALTH & SCIENCE UNIVERSITY · PI OKEN, BARRY S, SOUMYANATH, AMALA · 2005 to 2025
$7.2M
Building Research across Interdisciplinary Gaps (BRIDG) R90 Training Program - Administrative SupplementR90AT008924 · NCCIH · NATIONAL UNIVERSITY OF NATURAL MEDICINE · PI BRADLEY, RYAN D, ZWICKEY, HEATHER LEA · 2015 to 2025
$5.2M
Mentorship in Clinical Complementary and Integrative Health ResearchK24AT011568 · NCCIH · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BRADLEY, RYAN D · 2021 to 2025
$762k
Optimizing Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children with ADHD and Emotional DysregulationK23AT012068 · NCCIH · OREGON HEALTH & SCIENCE UNIVERSITY · PI JOHNSTONE, JEANETTE M · 2022 to 2025
$700k
Identification of Inhibitors of Phosphoglycerate Dehydrogenase (PHGDH)ZIATR000236 · NCATS · NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES · PI HALL, MATTHEW · 2015 to 2017
$593k
Eight Year Data from an Integrated Health Care SettingR21AT000892 · NCCIH · MINNEAPOLIS MEDICAL RESEARCH FDN, INC. · PI CULLITON, PATRICIA D · 2001 to 2002
$299k
Calgary Foundation Nutrition and Mental Health FundFoundation for Excellence in Mental Health Care Nutrition and Mental Health Research FundNCATS NIH HHS UL1 TR000128NCATS NIH HHS UL1TR000128NCATS NIH HHS UL1 TR002369NCATS NIH HHS UL1TR002369; UL1TR002733NCATS NIH HHS UL1 TR002733NCCIH NIH HHS K23 AT012068NCCIH NIH HHS K24 AT011568NCCIH NIH HHS R90 AT008924NCCIH NIH HHS R90AT008924; T32 AT002688; K23 AT012068-01NCCIH NIH HHS T32 AT002688NCCIH NIH HHS T32 #AT002688
6 · The paper itself

Abstract

backgroundThe Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula for children with ADHD and emotional dysregulation. The post-RCT open-label extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) on ADHD symptoms, height velocity, and adverse events (AEs).

methodsChildren aged 6-12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), received an 8-week OLE for a total of 16 weeks. Assessments included the Clinical Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric measures (height and weight).

resultsOf the 126 in the RCT, 103 (81%) continued in the OLE. For those initially assigned to placebo, CGI-I responders increased from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the CASI-5 composite score and subscales from week 8 to week 16 (all p-values < 0.01). The group taking 16 weeks of multinutrients had marginally greater height growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs between groups was found.

conclusionThe response rate to multinutrients by blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response rate in the group initially assigned to placebo improved significantly with 8 weeks of multinutrients and almost caught up with 16 weeks. Longer time on multinutrients did not result in greater AEs, confirming an acceptable safety profile.

Indexed as

Attention Deficit Disorder with HyperactivityMicronutrientsChildDietary SupplementsDouble-Blind MethodFemaleHumansMaleTreatment OutcomeMicronutrientsADHDChildrenMultinutrientsOpen-labelRCT

Identifiers

PMID37291464
PMCPMC10703999

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.