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Double-blind study: Micronutrient formulation is an effective and safe treatment for adult ADHD.

A micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardyshowed “statistically robust improvements” in the first-ever double-blind study to test the effectiveness and safety of a multivitamin-mineral treatment for adult ADHD. Researchers from the University of Canterbury and the University of Otago, New Zealand, randomized 80 adults diagnosed with ADHD to take either the micronutrient formulation or identical-looking placebo pills for 8 weeks. Most of the study participants had at least one psychiatric diagnosis in addition to ADHD. Additional diagnoses included multiple anxiety disorders, major depressive disorder, dysthymia, bipolar disorder, reading disability, and alcohol/substance misuse or dependence. The nutrient group reported more than double the improvement in attention, hyperactivity, and impulsivity symptoms, compared with the placebo group. Clinical psychologists rated more than twice as many people in the nutrient group ‘very much’ or ‘much’ improved in overall symptoms. They also rated moderate and severely depressed participants in the nutrient group as having nearly double the improvement in depression symptoms. Researchers found that the micronutrients were completely safe; there were no differences in side effects between the two groups.

British Journal of Psychiatry Daily Essential Nutrients Hardy Nutritionals Study on ADHD

Vitamin–mineral treatment of attention-deficit hyperactivity disorder in adults: double-blind randomised placebo-controlled trial.

Rucklidge JJ, Frampton CMA, Gorman B, Boggis A. The British Journal of Psychiatry. 2014 Feb;204(2): doi: 10.1192/bjp.bp.113.132126 [Epub ahead of print]

Micronutrient formulation outperforms Berocca Performance in reducing depression, anxiety, and stress in 91 earthquake survivors.

Following a 6.3-magnitude earthquake in Christchurch, New Zealand, researchers randomized 91 earthquake survivors to take one of two vitamin-mineral formulas (Berocca Performance or a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy. Then they measured symptoms of situation-induced depression, anxiety, and stress in these individuals, as well as 25 additional people who took no supplement (a control group). After 4 weeks, 20% of the control group, 43% of the Berocca Performance group, and 74% of the group taking the micronutrients showed significant improvement in depression, anxiety, and stress symptoms. Researchers concluded that this study supports micronutrients as an inexpensive and practical treatment for acute stress following a natural disaster, with a slight advantage to higher doses.

Shaken but unstirred? Effects of micronutrients on stress and trauma after an earthquake: RCT evidence comparing formulas and doses.

Rucklidge JJ, Andridge R, Gorman B, Blampied N, Gordon H, Boggis A. Human Psychopharmacology. 2012 Sep;27(5):440-54.

Micronutrient formulation reduces depression, anxiety, and stress in 17 earthquake survivors with ADHD.

A 7.1-magnitude earthquake in Christchurch, New Zealand created a natural experiment for measuring the protective effects of a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy on mood, anxiety and stress. Prior to the earthquake, researchers had assessed mood, anxiety and stress levels in a group of 33 adults diagnosed with attention deficit hyperactivity disorder, and they chose to repeat the same measures after the earthquake. Scores showed that the 16 participants taking micronutrients were more resilient to the effects of the earthquake than the 17 individuals not taking any supplement. This effect was particularly marked for depression scores.

Post-earthquake psychological functioning in adults with attention-deficit/hyperactivity disorder: positive effects of micronutrients on resilience.

Rucklidge JJ, Blampied, NM. New Zealand Journal of Psychology. 2011;40(4):51.

Micronutrient formulation greatly improves ADHD and other psychiatric disorders in 14 adults.

Researchers documented the impact of a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy in the treatment of 14 medication-free adults with attention deficit hyperactivity disorder. The adults’ additional psychiatric diagnoses included major depressive disorder, bipolar disorder II, generalized anxiety disorder, social phobia, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder with agoraphobia, and psychotic disorder not otherwise specified. During 8 weeks of micronutrient treatment, mood and hyperactivity/impulsivity symptoms normalized. Researchers also noted significant improvements on measures of anxiety, attention, stress, and quality of life. In follow-up, those who continued to take the micronutrients for 2-6 months experienced sustained or improved symptom relief.

Effect of micronutrients on behavior and mood in adults with ADHD: evidence from an 8-week open label trial with natural extension.

Rucklidge J, Taylor M, Whitehead K. Journal of Attention Disorders. 2011 Jan;15(1):79-91.

Micronutrient formulation greatly improves mood, behavior, and anxiety disorders in 9 children.

Researchers treated nine unselected children with mood and behavioral problems with a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy. The children’s psychiatric diagnoses included attention deficit hyperactivity disorder, bipolar disorder, depression, oppositional defiant disorder, obsessive-compulsive disorder, generalized anxiety disorder, Asperger syndrome, and Prader-Willi syndrome. After a minimum of 8 weeks of micronutrient treatment, the children’s behavior improved significantly in the following areas: anxious and depressed mood, thought problems, interpersonal relationship problems, attention problems, social problems, withdrawn behavior, disruptive behavior, delinquent behavior, aggressive behavior, and self-harm behavior.

Improved mood and behavior during treatment with a mineral-vitamin supplement: an open-label case series of children.

Kaplan BJ, Fisher JE, Crawford SG, Field CJ, Kolb B. Journal of Child and Adolescent Psychopharmacology. 2004 Spring;14(1):115-22.

Successful treatment of OCD with a micronutrient formula following partial response to Cognitive Behavioral Therapy (CBT): a case study.

Researchers detail an off-on-off-on trial of an 18-year-old male diagnosed with obsessive-compulsive disorder (OCD) and Asperger’s disordera who took a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy. The young man first underwent cognitive behavioral therapy (CBT) for one year with a modest response. Within a year thereafter, his anxiety became severe again and he began to experience major depression. After 8 weeks of using a vitamin-mineral formulation, his mood stabilized, his anxiety reduced, and his obsessions were in remission. Treatment was then discontinued for 8 weeks, during which time his obsessions, anxiety, and mood worsened. Reintroduction of the micronutrient formula again improved mood, obsession and anxiety symptoms within 8 weeks. After taking the formulation for 6 months longer, he experienced further improvements in mood and anxiety symptoms.

Successful treatment of OCD with a micronutrient formula following partial response to Cognitive Behavioral Therapy (CBT): a case study.

Rucklidge JJ. Journal of Anxiety Disorders. 2009 Aug;23(6):836-40.

Feasibility of a nutritional supplement as treatment for pediatric bipolar spectrum disorders.

Researchers investigated the therapeutic effects of a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy in 7 children with bipolar disorder. The children’s additional psychiatric diagnoses included attention deficit hyperactivity disorder, oppositional defiant disorder, major depressive disorder, generalized anxiety disorder, conduct disorder, and obsessive-compulsive disorder. The children experienced a 37% decrease in depression scores and a 45% decrease in mania scores over 8 weeks. Side effects were minor and transient—mostly temporary gastric discomfort.

Feasibility of a nutritional supplement as treatment for pediatric bipolar spectrum disorders.

Frazier EA, Fristad MA, Arnold LE. Journal of Alternative and Complementary Medicine. 2012 Jul;18(7):678-85.

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.

Can micronutrients improve neurocognitive functioning in adults with ADHD and severe mood dysregulation? A pilot study.

Rucklidge JJ, Harrison R, Johnstone J. Journal of Alternative and Complementary Medicine. 2011 Dec;17(12):1125-31.

Could yeast infections impair recovery from mental illness? A case study using micronutrients and olive leaf extract for the treatment of ADHD and depression.

A 24-year-old woman who experienced dramatic improvement in her ADHD and depression symptoms for more than 2 years while taking a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy later experienced a recurrence of her former psychiatric symptoms as a result of a severe yeast infection. Her physical symptoms included an overall flu-like feeling; a chronic sore throat and runny nose; cravings for sugary and starchy foods; gastrointestinal cramps; and rashes and itching on her legs, groin, genital and rectal areas. Psychiatric symptoms included severe moodiness, inability to experience pleasure, and chronic irritability. These physical and psychiatric symptoms persisted for several months despite her ongoing use of a prescription antifungal cream. The woman began taking four capsules of olive leaf extract (identical to our Hardy Nutritionals™ Olive Leaf Extract) as well as two capsules of probiotics (identical to our Hardy Nutritionals™ Greens & Probiotics) daily to treat the yeast infection, in addition to her regular therapeutic dose of the micronutrients. After a week and a half, the woman’s physical and psychiatric symptoms both improved, including disappearance of her rashes, cessation of the chronic itching, elimination of her runny nose, and improved mood and energy levels. After 2 months, she had returned to her previous level of function. During a year of follow-up, researchers found that the woman continued to enjoy relief from the physical and psychiatric symptoms caused by the yeast infection as long as she continued to take the Olive Leaf Extract.

Could yeast infections impair recovery from mental illness? A case study using micronutrients and olive leaf extract for the treatment of ADHD and depression.

Rucklidge JJ. Advances in Mind-Body Medicine. 2013 Summer;27(3):14-8.

Use of micronutrients attenuates cannabis and nicotine abuse as evidenced from a reversal design: a case study.

Scientists observed while conducting previous studies that many study participants whose psychiatric symptoms were treated successfully with a micronutrient formulation co-developed by Hardy Nutritionals® founder David Hardy tended to reduce or eliminate use of alcohol, cigarettes and cannabis on their own. This study details one case in which on-off micronutrient use resulted in off-on cigarette and cannabis smoking as well as off-on psychiatric symptoms. Micronutrients provide the necessary precursors and cofactors for adequate neurotransmitter production and regulation. In this way, micronutrients assist with mood regulation, help reduce anxiety, and directly affect brain reward circuitry, all of which can help individuals to successfully stop drug use.

Use of micronutrients attenuates cannabis and nicotine abuse as evidenced from a reversal design: a case study.

Harrison R, Rucklidge JJ, Blampied N. Journal of Psychoactive Drugs. 2013 Jun;45(2):168-178.

A randomised trial of nutrient supplements to minimise psychological stress after a natural disaster

After devastating flooding in southern Alberta in June 2013, we attempted to replicate a New Zealand randomised trial that showed that micronutrient (minerals, vitamins) consumption after the earthquakes of 2010-11 resulted in improved mental health. Residents of southern Alberta were invited to participate in a study on the potential benefit of nutrient supplements following a natural disaster. Fifty-six adults aged 23-66 were randomised to receive a single nutrient (vitamin D, n=17), a few-nutrients formula (B-Complex, n=21), or a broad-spectrum mineral/vitamin formula (BSMV, n=18). Self-reported changes in depression, anxiety and stress were monitored for six weeks. Although all groups showed substantial decreases on all measures, those consuming the B-Complex and the BSMV formulas showed significantly greater improvement in stress and anxiety compared with those consuming the single nutrient, with large effect sizes (Cohen's d range 0.76-1.08). There were no group differences between those consuming the B-Complex and BSMV. The use of nutrient formulas with multiple minerals and/or vitamins to minimise stress associated with natural disasters is now supported by three studies. Further research should be carried out to evaluate the potential population benefit that might accrue if such formulas were distributed as a post-disaster public health measure.

A randomised trial of nutrient supplements to minimise psychological stress after a natural disaster

Kaplan BJ, Rucklidge JJ, Romijn AR, Dolph M. Psychiatry Res. 2015 Aug 30;228(3):373-9.

Moderators of treatment response in adults with ADHD treated with a vitamin-mineral supplement

Dr. Julia Rucklidge conducted nutrient assays on study participants in her 8 week double-blind RCT using micronutrient treatment for adult ADHD.  Using this extensive data set, she performed a post-hoc analysis of the original study in an attempt to determine if blood levels of nutrients in adult ADHD patients could be used to predict whether or not they would respond to micronutrient treatment.  The blood markers measured were Vitamin D, Vitamin B12, Folate, Iron, Zinc, Copper, and Ferritin.

With the exception of Vitamin d (27% of participants deficient), nutrient deficiencies were slight or non-existent for the majority of participants at the beginning of the trial.  In spite of the fact that only one participant exhibited iron deficiency, low iron levels were associated with higher baseline depression scores (p=0.009).  No other nutrient significantly correlated with baseline psychiatric scores. 

Throughout the course of the trial, micronutrient treatment was associated with significant increases in blood Vitamin D, Vitamin B12, and Folate (all p<0.001), but only Vitamin D was also identified as one of the nutrient markers that showed a statistically significant effect on treatment response. 

The nutrient markers affecting treatment response were: ferritin, vitamin D, and copper.  Greater ferritin at baseline correlated with being an ADHD responder (p=0.027).  (ADHD response was defined as ≥30% decrease in symptom scores for a comprehensive combination of outcome measures.  Of the 64 original study participants with complete nutrient assays, 39 (60.9%) were identified as ADHD responders.)  Lower baseline vitamin D was predictive of greater improvements in depression (p=0.011) and global functioning (p=0.045) scores, and lower baseline copper levels predicted greater response in the depression (p=0.002) and clinical global improvement (p=0.007) outcome measures. 

From among the non-nutrient variables measured, the researchers identified developmental history as the only noticeable predictor of response. This means that people with a history of developmental risk factors (e.g., slow to talk, walk, read, toilet train) may benefit even more from micronutrient treatment than those who developed normally as a child.   It is also worth noting that several participants who reported alcohol or drug use at baseline later reported a reduction or cessation of these behaviours during micronutrient treatment, suggesting the possible value of nutrients in addiction therapy.

Only a few significant associations were identified between baseline biomarkers and outcomes, but, despite the difficulty in predicting the outcome for any given person, micronutrient treatment proved very effective – providing substantial ADHD symptom reduction for over half of the adults in this study.

Moderators of treatment response in adults with ADHD treated with a vitamin-mineral supplement

Rucklidge JJ, Johnstone J, Gorman B, Boggis A, Frampton CM. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Apr 3;50:163-71. doi:10.1016/j.pnpbp.2013.12.014. Epub 2013 Dec 26. PubMed PMID: 24374068.

Micronutrients reduce stress and anxiety following a 7.1 earthquake in adults with Attention-Deficit/Hyperactivity Disorder

The role of good nutrition for resilience in the face of stress is a topic of interest, but difficult to study. A 7.1 earthquake took place in the midst of research on a micronutrient treatment for Attention-Deficit/Hyperactivity Disorder (ADHD), providing a unique opportunity to examine whether individuals with ADHD taking micronutrients demonstrated more emotional resilience post-earthquake than individuals with ADHD not taking micronutrients. Thirty-three adults with ADHD were assessed twice following the earthquake using a measure of depression, anxiety and stress also completed at some point pre-earthquake (baseline). Seventeen were not taking micronutrients at the time of the earthquake (control group), 16 were (micronutrient group). While there were no between-group differences one week post-quake (Time 1), at two weeks post-quake (Time 2), the micronutrient group reported significantly less anxiety and stress than the controls (effect size 0.69). These between group differences could not be explained by other variables, such as pre-earthquake measures of emotions, demographics, psychiatric status, and personal loss or damage following the earthquake. The results suggest micronutrients may increase resilience to ongoing stress and anxiety associated with a highly stressful event in individuals with ADHD and are consistent with controlled studies showing benefit of micronutrients for mental health. 

Micronutrients reduce stress and anxiety following a 7.1 earthquake in adults with Attention-Deficit/Hyperactivity Disorder

Rucklidge JJ, Johnstone J, Harrison R, Boggis A. 2011. Psychiatry Research, 189:281-87.

Effect of Micronutrients on Insomnia in Adults: A Multiple-Baseline Study

Insomnia is a debilitating condition causing psychological distress and frequently comorbid with other mental health conditions. This study examined the effect of 8 weeks of treatment by broad spectrum micronutrients (Hardy Nutritionals® Daily Self Defense™) on insomnia using a multiple-baseline-across-participants open-label trial design. Seventeen adults were randomized to 1-, 2-, or 3-week baseline periods (14 completed). Self-report measures were the Consensus Sleep Diary–Morning (CSD-M), the Pittsburgh Insomnia Rating Scale (PIRS), and the Depression, Anxiety, Stress Scale (DASS). Baselines were generally stable. Treatment completers reported reliable and clinically significant change in insomnia severity (PIRS), in depression, stress, and anxiety (DASS), and on at least two aspects of sleep measured by the CDS-M. All completers were treatment-compliant, and side effects were minimal. Nutritional supplementation is shown to be a novel, beneficial treatment for insomnia in adults. Follow-up research using placebo-controlled designs as well as comparisons to cognitive-behavioral and other treatments is recommended.

Effect of Micronutrients on Insomnia in Adults: A Multiple-Baseline Study

Joanna Lothian, Neville M. Blampied, Julia J. Rucklidge. Clinical Psychological Science. May 23, 2016.doi:10.1177/2167702616631740