SelenoPrecise approved by EFSA

The European Food Safety Authority (EFSA) has reviewed the extensive safety documentation on SelenoPrecise and concluded that the product does not present any safety concern.


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Selenium references – a selection

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Immune system
The function of the immune system is closely related to the interactions between free radicals and antioxidants. A sufficiently high concentration of antioxidants in the body seems important for fighting infections [A-863, A-3695].
Deficiency of selenium is accompanied by a decrease of the immune function [A-826], while supplementation with selenium has marked immunostimulatory effects [A-7350]. In an animal trial, supplementation with selenium was able to restore age-related immune decline [A-7351].
The result of a controlled study of selenium supplementation to patients with severe inflammatory response syndrome caused by infection was improved clinical outcome and reduction of the incidence of acute renal failure [A-5991]. In the most critically ill patients, there was a significantly lower mortality in the group supplemented with selenium. In a study of 725 institutionalised elderly persons, supplementation with 100 ?g selenium and 20 mg zinc improved immunity significantly compared with placebo [A-5471].

Epidemiological studies have shown a correlation between high selenium status and lower risk of certain forms of cancer, eg. bladder cancer [A-7259] and prostate cancer [A-7167], and high dietary selenium intake or high selenium status is associated with lower cancer mortality in general [A-6218]. Biochemical studies [A-6753] and other studies have demonstrated promising possibilities for the use of selenium alone or in combination with other antioxidants for the primary prevention ("chemoprevention") of cancer [A-6238] or prevention of recurrence after surgery [A-5176]. Certain selenoproteins seem to play a protective role in development of breast cancer, and possession of a certain genotype that requires elevated levels of selenium to retain the basal level of protection is implicated in some cases [A-6947]. Five well controlled, double-blind trials have confirmed a positive effect of selenium supplementation (alone or used with other substances) on cancer forms.

In former skin cancer patients who received 200 ?g selenium daily for a period of 4.5 years, a significant reduction of total cancer mortality, of the incidence of lung cancer, prostate cancer, and colorectal cancer was seen [A-3676]. In a more recent report including results from two additional years, the reductions were maintained, however, only prostate cancer remained significantly reduced [A-6901, A-6885]. A slight increase in nonmelanoma skin cancer was found in men with a high baseline plasma level of selenium, although this result hovered at the margin of statistical significance and is inconsistent with findings from other experiments [A-6885]. In certain areas of China the prevalence of hepatic carcinoma (HC) is high due to a large hepatitis B infection rate. In a placebo controlled study of 226 hepatitis B antigen carriers supplemented daily with 200 ?g of selenium yeast or placebo no case of HC occured in the selenium group over 4 years, while seven individuals in the placebo group developed HC. Fortification of table salt with selenium among 130.000 chinese people at risk from five townships lowered the incidence of HC by 35% after six years [A-7140]. Similarly, in a controlled study in 18000 persons from a high-risk area for liver cancer, selenium supplementation was able to decrease the incidence of new liver cancers significantly [A-7292]. In a large placebo-controlled study involving 29584 persons, some supplemented with selenium, beta-carotene and vitamin E, a significant lowering of stomach cancer was found [A-1847]. One of the largest and most recent placebo-controlled studies among Europeans using a dose of antioxidants, including selenium and zinc, found a signicficant 31% reduction of cancer incidence in men, but not in women [A-7267].

Viral infections
Studies have shown that a deficiency of selenium may aggravate the effects of viral infections, like influenza [A-6446] and HIV [A-4500, A-4506], and may even play a role in infections with hemorrhagic fever viruses, like Ebola [A-7349].
If a normally harmless virus like the coxsackie virus infects a selenium deficient host, it can mutate into a virulent form, causing myocarditis [A-7184]. Similarly, Se-deficient mice infected with a mild influenza virus developed much more severe and prolonged lung inflammation than Se-adequate mice [A-6446]. HIV infected patients with a selenium deficiency are also about 20 times more likely to die from HIV-related causes than those with adequate selenium levels [A-4500]. It has even been suggested that ensuring an adequate intake of selenium may reduce the likelihood of an exposed person being infected by HIV [A-6431]. Selenium deficiency is in this context defined as a plasma level below ? 85 ?g/l, a level not attained in many northern European countries [A-6710].

Cardiovascular disease
It is documented that low selenium status is inversely associated with platelet aggregation and increased risk for cardiovascular disease in men with coronary artery disease [A-4414]. In a cohort of 3387 middle-aged Danish men, a selenium level below 79 ?g/l was associated with a significantly increased risk of ischaemic heart disease [A-1461]. Keshan disease is a cardiomyopathy seen in persons infected with coxsackie virus and with extremely low selenium status [A-6200]. A low blood level of selenium has also been associated with acute myocardial infarction [A-328].
In a controlled trial, administration with selenium and coenzyme Q10 to patients admitted with acute myocardial infarction improved biochemical parameters, the functioning of the heart, and seemed to affect survival positively after one year [A-2398].

Fertility and pregnancy
Researchers have identified a selenoprotein that helps to rid developing sperm cells of dangerous radical molecules and also functions as a part of the structural base of mature sperm [A-5710]. A trial conducted in Scotland in which 69 infertile men received selenium supplements combined with small amounts of vitamins did not shown any effect on the number of sperm cells, but the men who received the seleniumgroup in this trial were found to have significantly higher sperm cell motility. In the selenium group 11% acheived paternity compared with none in the placebo group. [A-5630].
In another controlled trial supplementation with selenium and vitamin E decreased semen oxidative load and increased sperm cell motility [A-6853]. Low intake of selenium also seems to be associated with a greater risk of preeclampsia [A-7025].

There are indications that selenium is important to the function of the brain. In human studies, low selenium was associated with depression, anxiety, confusion and hostility [A-6710]. High selenium diets or supplementation with selenium, on the other hand, have been able to improve clearheaded-confused scores and significantly decrease anxiety and tiredness in younger persons [A-6710]. A controlled study in elderly, healthy persons did not show this effect [A-7509], but selenium supplementation improved mood in a controlled trial with younger subjects [A-3072].