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Recently, researchers from several universities who have studied and published research on the effectiveness of Daily Essential Nutrients, the world’s most complete supplement for the treatment of ADHD, presented at the Annual International Conference on ADHD 2023.
The speakers were Noshene Ranjbar, Associate Professor at the University of Arizona, Alisha Bruton of Oregon Health & Science University, L. Eugene Arnold of Ohio State University, and Lisa Robinette, Ph.D. Candidate at Ohio State University. Each has extensive experience researching the connection between nutrition and psychiatry.
Their paper, “The Micronutrients for ADHD in Youth (MADDY) Study”, which was published in the Journal of the American Academy of Child and Adolescent Psychiatry, delved into the effects of Daily Essential Nutrients, a micronutrient supplement formulated by Hardy Nutritionals. The study focused on ADHD symptoms in children aged 6-12 and was the product of a collaborative effort of four experts in ADHD, nutrition, and clinical trials. Over the course of more than a year, these experts engaged in extensive email communication and weekly teleconferences to formulate the study protocol. Guided by prior research suggesting micronutrient treatment's efficacy in improving irritability and mood dysregulation, the study honed in on these aspects as key features of ADHD.
To complete the study, an Investigational New Drug (IND) application was meticulously prepared and submitted to the United States Food and Drug Administration (FDA). The FDA granted approval after reviewing analyses of the micronutrient supplement. Simultaneously, Health Canada also approved the study and the use of micronutrients. The supplement, Daily Essential Nutrients (DEN), and the matching placebo supply were provided by Hardy Nutritionals.
The MADDY study, marked by its distinctive design and international reach, sought to unravel the impact of micronutrient supplementation on ADHD symptoms in children. The incorporation of qualitative research, aimed at understanding parents' perspectives, added a nuanced layer to the study, aiming to address potential unmet needs within this demographic.
Overall, the MADDY study strived to contribute comprehensive insights into the role of micronutrient supplementation in mitigating ADHD symptoms in children. By considering both behavioral outcomes and safety considerations, the study aimed to provide a holistic understanding of the potential benefits and challenges associated with this novel approach to treatment.
Study Population and Recruitment:
The recruitment process involved reaching out to potential participants through various channels, including affiliated child psychiatry divisions, children's hospitals, referrals from local pediatricians, mental health providers, and social media platforms like Facebook. Eligibility criteria were defined, requiring participants to be between six and 12 years old, willing to swallow 9–12 capsules daily, meeting ADHD criteria, and displaying at least one symptom of irritability or anger. The study aimed to enroll 135 participants across the three sites.
Randomization and Micronutrient Formula:
To ensure a fair and unbiased allocation of participants, a randomization scheme was generated, resulting in a 3:2 ratio for active treatment and placebo, respectively. Daily Essential Nutrients (DEN), comprising 39 vitamins, minerals, amino acids, and antioxidants, served as the micronutrient supplement. Participants followed a titration schedule over the initial four weeks to gradually reach the therapeutic dose.
Dosing Adjustment and Assessment Visits:
Throughout the study, research staff maintained regular contact with parents, checking in at week one via phone to assess tolerance, compliance, and any changes in symptoms. Dosing adjustments were considered, with a maximum of 12 capsules for participants aged 9–12 based on factors such as reported side effects, ability to swallow capsules, and perceived symptom improvement. Enrollment visits included essential components like fasting blood draws, completion of questionnaires, and the collection of various biological samples for potential future analyses.
Follow-up Visits and Adherence:
Upon completing the study, participants were given the option to purchase the supplement at a discounted rate. Follow-up visits at 1, 2, and 12 months were conducted to ascertain whether the child continued with the supplement. Adherence to the regimen was monitored through the return of unused capsules and the utilization of a pill reminder app.
Assessment Measures and Data Analysis:
The primary outcome measure, the Child & Adolescent Symptom Inventory-5 (CASI-5), played a pivotal role in evaluating the study's objectives. The overarching aim was to explore behavioral changes driven by micronutrients and validate the existence of an irritable ADHD subtype. Safety considerations were paramount, involving the monitoring of adverse events and regular reviews conducted by a Data Safety Monitoring Board.
The 8-week Micronutrients for ADHD in Youth (MADDY) Study, involving 126 children with ADHD and irritable mood, aligns with prior research, demonstrating significant global improvement when using Daily Essential Nutrients for focus, attention, and mood stability. Notably, participants in the micronutrient group showed a threefold increase in the likelihood of being treatment responders compared to the placebo group (54% vs. 18%) based on blinded CGI-I ratings, replicating results from previous studies. The micronutrient group demonstrated a trend toward greater reduction in irritability-related symptoms, and adult/teacher ratings on the CASI-5 Peer Conflict subscale showed a significant between-group difference favoring micronutrients. The micronutrient treatment was well-tolerated with a 93% retention rate, and participants grew, on average, 6 mm more in height compared to the placebo group. The study also highlighted potential positive effects on height growth velocity compared to stimulant medications. The study clearly demonstrated the safety and acceptability of clinical-strength micronutrient supplementation in ADHD treatment.