drugset / Trial / NCT03252522
Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study
Phase 1/2
Completed
135 enrolled
Oregon Health and Science University
Foundation for Excellence in Mental Health Care · collabNational University of Natural Medicine · collabOhio State University · collabThe Waterloo Foundation · collabUniversity of Lethbridge · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This proposed research will use randomized control trial (RCT) methodology and compare micronutrients with placebo in 135 children with ADHD.
Timeline
- Start
- 2018-04-23
- Primary completion
- 2020-07-10
- Completion
- 2021-05-31
Outcome
Mixed primary results
paper For the CGI-I, 54% of the micronutrient and 18% of the placebo group were responders (risk ratio = 2.97, 97.5% CI = 1.50, 5.90, p < .001). PMID 34303786 ↗
paper However, the between-group difference was not significant (mean change = -0.02; 97.5% CI = -0.16, 0.12, effect size = 0.07, p = .70). PMID 34303786 ↗
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 Mar 3. doi: 10.1007/s12011-026-05017-5. Online ahead of print.
- Robinette 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Broad Spectrum Micronutrients | Other / unclassified | — | Oral |