Life Elevated Through Daily Essential Nutrients
The Daily Essential Nutrient Formula has been found in several landmark research cases to significantly help with
The Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP) recently (May 25, 2022) published a ground-breaking double-blind study supporting the safety and efficacy of Hardy Nutritionals® Daily Essential Nutrients (DEN) for children with mood dysregulation and ADHD.
Daily Essential Nutrients is available in powder and/or capsule form. If your child struggles with swallowing pills you can try the flavored powder, available here.
The study "Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth: A Placebo-Controlled Randomized Clinical Trial," evaluated the benefits of DEN for unmedicated children ages 6-12 who suffer from ADHD and irritability and was featured on the cover of the May 2022 issue of the JAACAP journal.
A double-blind, randomized, placebo-controlled trial design is considered the gold standard of research and provides reliable results. The study ensured that participants, their parents, clinicians, and researchers did not know who received the micronutrients or the placebo.
In addition to ADHD symptoms such as inability to focus and hyperactivity, the researchers evaluated peer conflict, oppositional defiance, and disruptive mood dysregulation in the children.
In the results, the DEN treatment provided a "significant benefit" over the placebo in children with ADHD and irritability.
You can read the whole groundbreaking research here.
Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth: A Placebo-Controlled Randomized Clinical Trial
Objective: To evaluate whether micronutrients (vitamins/minerals) benefit attention-deficit/hyperactivity disorder (ADHD) and irritability in a North American pediatric sample.
Method: A three-site 8-week placebo-controlled randomized clinical trial of micronutrients was conducted in unmedicated children ages 6-12 with ADHD and at least one impairing irritability symptom by parent report on the Child and Adolescent Symptom Inventory-5 (CASI-5). A priori-defined primary outcomes were Clinical Global Impression-Improvement (CGI-I) (CGI-I of 1 or 2 = treatment responder) and parent-rated CASI-5 composite score of ADHD, oppositional defiant, disruptive mood dysregulation, and peer conflict symptoms, including impairment scores.
Results: Of 135 randomized (mean age 9.8 years), 126 (93%) comprised the modified intention-to-treat population. Blinding was maintained. 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<0.001). CASI-5 composite scores improved significantly for both groups (p<0.01) with a mean change of -0.31 (95% CI: -0.39, -0.23) in the micronutrient group and a mean change of -0.28 (95% CI: -0.38, -0.19) in the placebo group. But the between group difference was not significant (mean change = -0.02; 97.5% CI: -0.16, 0.12, ES = 0.07, p=0.70). The micronutrient group grew six millimeters more than the placebo group (p=0.002). No serious adverse events nor clinically significant changes from baseline in blood and urine tests occurred.
Conclusion: Micronutrients showed global benefit over placebo by blinded clinician rating, but not by parent-report CASI-5 composite rating in a population with ADHD and irritability. Micronutrients showed greater height growth. Micronutrients were well tolerated and the majority adhered to the number of capsules prescribed. This RCT replicates safety and efficacy reported for ADHD in two smaller trials of a similar formula containing all vitamins and known essential minerals in amounts between the Recommended Dietary Allowance and Upper Tolerable Intake Level.
Vitamin-mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo-controlled trial.
Evaluation of broad-spectrum micronutrient (vitamins and minerals) treatment for childhood ADHD has been limited to open-label studies that highlight beneficial effects across many aspects of psychological functioning.
This is the first fully blinded randomized controlled trial of medication-free children (n = 93) with ADHD (7-12 years) assigned to either micronutrients (n = 47) or placebo (n = 46) in a 1:1 ratio, for 10 weeks. All children received standardized ADHD assessments. Data were collected from clinicians, parents, participants and teachers across a range of measures assessing ADHD symptoms, general functioning and impairment, mood, aggression and emotional regulation.
Intent-to-treat analyses showed significant between-group differences favoring micronutrient treatment on the Clinical Global Impression-Improvement (ES = 0.46), with 47% of those on micronutrients identified as 'much' to 'very much' improved versus 28% on placebo. No group differences were identified on clinician, parent and teacher ratings of overall ADHD symptoms (ES ranged 0.03-0.17). However, according to clinicians, 32% of those on micronutrients versus 9% of those on placebo showed a clinically meaningful improvement on inattentive (OR = 4.9; 95% CI: 1.5-16.3), but no group differences on improvement in hyperactive-impulsive symptoms (OR = 1.0; 95% CI: 0.4-2.5). Based on clinician, parent and teacher report, those on micronutrients showed greater improvements in emotional regulation, aggression and general functioning compared to placebo (ES ranged 0.35-0.66). There were two dropouts per group, no group differences in adverse events and no serious adverse events identified. Blinding was successful with guessing no better than chance.
Micronutrients improved overall function, reduced impairment and improved inattention, emotional regulation and aggression, but not hyperactive/impulsive symptoms, in this sample of children with ADHD. Although direct benefit for core ADHD symptoms was modest, with mixed findings across raters, the low rate of adverse effects and the benefits reported across multiple areas of functioning indicate micronutrients may be a favorable option for some children, particularly those with both ADHD and emotional dysregulation. Trial registered with the Australian New Zealand Clinical Trials Registry ACTRN12613000896774.
Can micronutrients improve neurocognitive functioning in adults with ADHD and severe mood dysregulation? A pilot study.
Researchers studied the impact of a micronutrient formulation co-developed† by Hardy Nutritionals® founder David Hardy on neurocognitive functioning in 14 adults with attention deficit hyperactivity disorder (ADHD) and severe mood dysregulation over an 8-week period. Significant improvement was observed in the ADHD-micronutrient group, but not the control group, across a range of verbal abilities, including verbal learning, verbal cognitive flexibility and fluency, and verbal inhibition. These neurocognitive improvements were large and consistent with improved psychiatric functioning.
†The micronutrient formulation studied was a pre-2013 version of Truehope EMPowerplus which was co-formulated by David Hardy and Anthony Stephan. Truehope EMPowerplus is a registered trademark of The Synergy Group of Canada Inc., which was co-founded by David Hardy and Anthony Stephan in 1999. David Hardy officially resigned as a shareholder of The Synergy Group of Canada Inc. and director of Truehope Nutritional Support Ltd. in 2013 to focus his efforts exclusively on Hardy Nutritionals®.