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In every clinical trial on Daily Essential Nutrients which measured nutrient blood levels, folate and vitamin B12 were among the several nutrients for which blood levels increased significantly. Of these, vitamin B12 was most likely to be outside of the range considered to be "normal". Therefore, if a person is using Daily Essential Nutrients or the very similar Optimal Balance formula and their blood levels of folate, vitamin B12, or certain other nutrients (including vitamin D) increase significantly, we can very confidently say that the increase is a direct result of the supplementation.
Customers often reach out to us with concerns about one or more of these nutrients falling outside of the "normal range" on their blood tests. The relevant question is not whether or not these nutrients are outside of the standard range considered to be "normal" in unsupplemented individuals but rather if the elevated blood levels of these nutrients are actually harmful. Neither peer-reviewed safety studies (both short-term or long-term) nor controlled and randomized clinical trials have shown evidence of significant side effects or signals of harm in either children or adults consistently taking a dose of 12 capsules per day of Daily Essential Nutrients, and many such studies have been conducted (see the research at www.HardyNutritionals.com/studies).
Obviously, research studies specific to the product itself are the strongest form of data. However, in addition to the research which has evaluated Hardy Nutritionals' formulas directly, we can estimate safety based on recommended nutrient intake ranges published by various government agencies and academic institutions. In the United States, one of the Dietary Reference Intakes published by the Institute of Medicine for many nutrients is a dose called the "Tolerable Upper Intake Level" (UL). This is the oral dose considered to be safe when ingested daily on a continuous basis by the average individual of a given age category (i.e. persons with no disease states or other special considerations relevant to that nutrient).
There is no UL established for vitamin B12 in either adults or children, due to no clear evidence of harm from ingesting even very high doses. And much higher doses than those in Daily Essential Nutrients have been extensively studied. Therefore, if vitamin B12 is elevated in the blood simply because it is being supplemented there should be no cause for concern.
There is an established UL for folate. In 1998 the basis for the UL was that supplemental folate was able to mask symptoms of B12 deficiency (as a factor in anemia) and as a result doctors could not detect the deficiency it until the neurological effects had become permanent. Supplementing B12 along with folate removes this risk. When the DRI’s for folate were published little was known about the different forms of folate other than the fact that food forms had no adverse effects at any measured level of intake. Recent data suggest that folic acid may have a safety concern because intakes of folic acid beyond the body’s ability to reduce it to THF (tetrahydrofolate) lead to unmetabolized folic acid in the body, which does have some adverse effects. Both versions of Daily Essential Nutrients use the food forms of folate and B12 so the concerns around folic acid are not pertinent to the formula. Therefore, because Daily Essential Nutrients very effectively, reliably, and safely increases vitamin B12 levels in the body (as demonstrated above), even if folate levels were to rise outside of the range which is considered to be "normal" in unsupplemented individuals, the risk of these levels causing any harm is greatly reduced due to the simultaneous supplementation of adequate vitamin B12. This is one of the many examples of how supplementing with a well-balanced, broad-spectrum multi-nutrient formulation such as Daily Essential Nutrients is safer and more effective than supplementing with only one or several select nutrients.
Finally, it should be noted that theoretical risks must always be weighed against the clinical reality. Every medical decision should involve a risk-benefit analysis, which will be unique to the circumstances of each individual. For example, if Daily Essential Nutrients appears to make no difference to a person's health and they find that it increases the levels of certain vitamins in their blood tests, it would cause no obvious harm to reduce the dose of the supplement since the supplement is not providing any apparent benefit. However, if Daily Essential Nutrients is delivering measurable health benefits to an individual with no observable clinical signs of harm or toxicity and then this individual finds that the quantities of certain of the supplemented vitamins are elevated on their blood tests, any theoretical risks this may pose must be contrasted with the real and observable benefits. In this case, very possibly it would do more harm than good to reduce the dose of the Daily Essential Nutrients.
In summary, elevated vitamin B12 and folate are to be expected from supplementation with the Hardy Nutritionals micronutrient formulas. The phenomenon is known and well documented in peer-reviewed research. The oral doses of these nutrients are within recommended safe intake ranges for adults when the Hardy Nutritionals products are taken as recommended, and therefore no harm would be expected from these elevated blood levels. And, no evidence of harm has been observed from these Hardy Nutritionals formulas in extensive independent research and clinical use in spite of the fact that blood levels of certain nutrients are elevated.