Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension.
Background: The 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 wee...
| Publicado en: | European Child & Adolescent Psychiatry Vol. 33; no. 5; pp. 1355 - 1368 |
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| Autores principales: | , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Springer Nature
May2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=178046251&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 178046251 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10188827 EJ3 jtl: European Child & Adolescent Psychiatry issn: 10188827 maglogo: N pubinfo: dt: May2024 vid: 33 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 178046251 164167603 178046251 178046251 10.1007/s00787-023-02236-2 178046251 ppf: 1355 ppct: 13 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension. aug: au: Leung, Brenda M. Y. Srikanth, Priya Robinette, Lisa Bruton, Alisha M. Tost, Gabriella Hatsu, Irene Arnold, L. Eugene Johnstone, Jeanette M. affil: https://ror.org/044j76961 Faculty of Health Sciences, University of Lethbridge, 4401 University Drive, Lethbridge, AB, Canada sug: subj: Micronutrients Therapeutic Use Attention Deficit Hyperactivity Disorder Drug Therapy Treatment Duration Body Height Body Weight Evaluation Treatment Outcomes Human Funding Source Child Random Assignment Clinical Assessment Tools Scales Anthropometry Descriptive Statistics Randomized Controlled Trials Pretest-Posttest Control Group Design Comparative Studies Adolescence Child: 6-12 years Adolescent: 13-18 years ab: Background: The 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). Methods: Children 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). Results: Of 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. Conclusion: The 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. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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