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Ever wondered about the impact of using micronutrients daily for extended periods of time? A study published in the Journal of Alternative and Complementary Medicine in 2019 [1] examined the safety and effects of micronutrient supplementation over the long term, including specifically, Daily Essential Nutrients.
The study consisted of 17 children and 17 adults. All the children were taking Daily Essential Nutrients (DEN) with an average dose of 10.53 pills per day for the treatment of ADHD for 1.54 years. The adults had been consuming the micronutrients for an average of 3.75 years. The average daily number of pills consumed by the adults was 9.88. Of the 17 adults, four were taking micronutrients for ADHD, the remainder for the treatment of symptoms associated with depression/anxiety.
Blood tests taken during the course of the study showed that one adult had evidence of iron overload. Further testing confirmed a diagnosis of pre-existing hemochromatosis. This individual was advised to stop taking the nutrients, given the inclusion of iron in the formula. One child with elevated copper (19.6 mmol/L) was sent for a repeat blood test, and the second copper level came back within the normal range (13 mmol/L).
It is of note that Daily Essential Nutrients is now available in an iron- and copper-free version here.
With the exception of B12, none of the participants showed elevated or statistically significant increases in blood-nutrient levels. It's important to know that this is expected and is not harmful. In fact, the Institute of Medicine has set no Upper Level for vitamin B12 safety and tolerability because, in spite of increased blood levels during supplementation, there are no known adverse effects from any dose of B12.
High vitamin B12 is a cause for concern in unsupplemented individuals, however, as it can be a sign of kidney, liver, or blood disorders that can lead to cancer. In summary, if high vitamin B12 levels are simply a result of supplementation, it simply means that the supplemental vitamin B12 is bioavailable and is being absorbed into the body. It is only in the absence of vitamin B12 supplementation that high B12 blood levels are a sign of pathology and are cause for concern.
From reports and double-blind studies over the last 20 years, we know optimal wellness is achieved at about a year of taking DEN at the clinical dose of 12 capsules daily. Many individuals also report after finding stability for a time that they can usually reduce their intake of Daily Essential Nutrients. This is not the case for everyone, however, which is why long-term safety matters.
In the study, the participants showed significant improvement in all measures of mood regulation, anxiety, and ADHD. Based on the CGI-I scale, 91% of participants were identified as either much or very much improved. The remaining 7% were identified as being mildly improved. In terms of reports of side effects, two parents of child participants and two adults reported stomachaches and headaches, but these were only present within the first month of consuming the micronutrients. In our experience, these effects are transient and are overcome once the body acclimates to the nutrient levels. No long-term adverse effects or serious adverse effects were reported.
Is Daily Essential Nutrients safe to take for a lifetime?
When taken as recommended, the levels of all the vitamins and minerals in Daily Essential Nutrients, except magnesium, are within the Tolerable Upper Intake Levels published by the Institute of Medicine (US) or comparable regulatory bodies in other jurisdictions. The only known adverse effect of magnesium at the intake levels in Daily Essential Nutrients is diarrhea/loose stools, which is usually transient and resolves within days or is easily explained by a known health condition.
At Hardy Nutritionals, we know of individuals who have consistently consumed Daily Essential Nutrients and/or its substantially similar predecessor formulations at the full clinical dose (12+ capsules per day) for nearly two decades. They say they would not discontinue taking the supplement because they do not want to risk the return of the debilitating mental illness from which it saved them. We have seen others who, after many years of clinical dosing, find that they can maintain their symptom response on a reduced dose so they may continue to supplement at a lower intake level. Participants in over 40+ clinical trials have undergone scrutiny and follow-up, including both symptom evaluations and analysis of biological samples, for up to five years.
Sources: [1] An Observational Preliminary Study on the Safety of Long-Term Consumption of Micronutrients for the Treatment of Psychiatric Symptoms AU1 c Julia J. Rucklidge, PhD,1 Matthew J. F. Eggleston, MD,2 Breanne Ealam, BA (Hons),1 Ben Beaglehole, MD,3 and Roger T. Mulder, MD