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The Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP) recently 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 capsule form with samples 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. Participants taking DEN were three times more likely than placebo recipients to be treatment responders, based on clinician ratings citing "much" or "very much" improved in overall symptoms. Parents also rated the children in the DEN group as being significantly less aggressive towards their peers than in the placebo group.
In contrast with conventional ADHD treatments, which are known to suppress appetite and cause growth suppression, participants in the DEN group also grew statistically significantly taller (6mm in only 8 weeks) compared to the placebo group.
In this study, DEN was also deemed safe by researchers. The children taking the specialized blend of micronutrients of DEN showed no differences in side effects compared to the placebo group. Despite the high dosage, researchers stated, "The micronutrient treatment was both acceptable and well-tolerated, with a 93% retention rate...This finding is consistent with previous micronutrient studies." The dosage of nutrients in DEN, while high, is well within established safety limits.
After the 8-week study period, researchers noted not only improvements in overall ADHD symptoms but also improvements in the following:
This landmark double-blind study replicates a previous double-blind study in children with ADHD also carried out using DEN and comes on the heels of many other blinded and non-blinded clinical trials which all show marked improvements in study participants for symptoms such as mood dysregulation, anger, and irritability.
There are currently three additional double-blind studies underway on Daily Essential Nutrients for mood and anxiety. While we wait for more encouraging results from these ongoing studies, we are excited to continue to provide an effective non-pharmacological alternative for mental health.
This research was carried out independently and funded through private donations to the Nutrition and Mental Health Research Fund managed by the Foundation for Excellence in Mental Health Care (FEMHC) and a direct grant from FEMHC and the Gratis Foundation. The authors also received support from the National Institutes of Health (NIH) National Center for Complementary and Integrative Health.
Daily Essential Nutrients is available in both capsule and powder form at HardyNutritionals.com. Health practitioners who read the study are eligible for Continuing Medical Education credits (CME) by logging in here.
View the full study here: https://doi.org/10.1016/j.jaac.2021.07.005