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Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension
by
Hatsu, Irene
, Leung, Brenda M. Y
, Srikanth, Priya
, Bruton, Alisha M
, Robinette, Lisa
, Tost, Gabriella
, Arnold, L. Eugene
, Johnstone, Jeanette M
in
Adverse events
/ Attention deficit hyperactivity disorder
/ Body height
/ Children
/ Critical incidents
/ Efficacy
/ Emotional regulation
/ Groups
/ Hyperactivity
/ Labeling
/ Measures
/ Micronutrients
/ Pediatrics
/ Placebos
/ Ratings & rankings
/ Response rates
/ Safety
/ Symptoms
/ Youth
2024
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Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension
by
Hatsu, Irene
, Leung, Brenda M. Y
, Srikanth, Priya
, Bruton, Alisha M
, Robinette, Lisa
, Tost, Gabriella
, Arnold, L. Eugene
, Johnstone, Jeanette M
in
Adverse events
/ Attention deficit hyperactivity disorder
/ Body height
/ Children
/ Critical incidents
/ Efficacy
/ Emotional regulation
/ Groups
/ Hyperactivity
/ Labeling
/ Measures
/ Micronutrients
/ Pediatrics
/ Placebos
/ Ratings & rankings
/ Response rates
/ Safety
/ Symptoms
/ Youth
2024
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While trying to remove the title from your shelf something went wrong :( Kindly try again later!
Do you wish to request the book?
Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension
by
Hatsu, Irene
, Leung, Brenda M. Y
, Srikanth, Priya
, Bruton, Alisha M
, Robinette, Lisa
, Tost, Gabriella
, Arnold, L. Eugene
, Johnstone, Jeanette M
in
Adverse events
/ Attention deficit hyperactivity disorder
/ Body height
/ Children
/ Critical incidents
/ Efficacy
/ Emotional regulation
/ Groups
/ Hyperactivity
/ Labeling
/ Measures
/ Micronutrients
/ Pediatrics
/ Placebos
/ Ratings & rankings
/ Response rates
/ Safety
/ Symptoms
/ Youth
2024
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Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension
Journal Article
Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension
2024
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Overview
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.
Publisher
Springer Nature B.V
Subject
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