New tightening of vitamin D prescription for bone fragility in healthy adults. This was indicated by the Italian Medicines Agency (Aifa), which updated the appropriateness criteria based on new scientific evidence which also clarified the lack of benefits against Covid19.
However, the choice is not liked by the doctors who have to prescribe it. “It is based on an economic logic, but short-sighted from a clinical and prevention point of view. Experimental studies show how important vitamin D is for the proper functioning of various systems, from the immune to the skeletal. The result is that we continue to recommend it and citizens almost always pay for it on their own”, explains Annamaria Colao, president of the Italian Society of Endocrinology (SIE). The use of vitamin D-based supplements, AIFA specifies, “is one of the most debated topics in the medical field, a source of controversy and strongly antithetical beliefs”. Synthesized with the sun’s rays and become famous as a cure for childhood rachidism, this hormone (cholecalciferol, calcifediol) has always been used to reduce the risk of fractures due to osteoporosis, but not only. “Vitamin D circulating in the blood – explains the endocrinologist – is a parameter of good health, while its deficiency is linked to a high inflammatory level in the body, with all the related diseases, from the development of tumors, to the worsening of obesity, diabetes, hypertension”. Note 96 was published in 2019 to limit the prescription of vitamin D by the National Health System and had brought “a saving of several tens of millions a year, albeit with strong regional variability”, as indicated by the former director General Aifa Nicola Magrini. Now, the new determines 48/2023 further lowers the levels of the hormone in the blood for which the vitamin can be prescribed. To make it “necessary” are the new published evidence, Aifa points out, i.e. two large randomized clinical trials, one published in Nejm in 2022 and one in Jama in 2020. Both concluded that supplementation with more than adequate doses of vitamin D (2000 IU per day) and for several years did not reduce the risk of fracture in the healthy population, with no risk factors for osteoporosis. These results, Colao specifies, “show that alone it does not prevent fractures, and this is true because bone fragility can also be due to nutritional deficiencies throughout life and other pathologies, which the study does not consider”. Vitamin D is also widely prescribed by pediatricians to boost the immune system, because those with low blood levels generally respond less well to infections. The new Aifa determination, however, specifies that the scientific literature on its use against Covid-19 shows how “the effectiveness of vitamin D has been denied by correctly designed and conducted studies” and that “there are no elements to consider it an important aid “. In these studies, however, Professor Colao points out, “patients who fell ill with Covid and were given vitamin D in addition to therapies were enrolled. Supplementation has not shown benefits, but it is not surprising that something that serves for prevention , if used as a cure, has no effect”. In any case, concludes the president of the endocrinologists, it is important, “as Aifa also underlines, not to underestimate the risks of overdose and improper use of vitamin D-based preparations”.