The Italian Medicines Agency Aifa has updated Note 96 on the prescribing appropriateness criteria of supplementation with vitamin D and its analogues (colecalciferol, calcifediol), for the prevention and treatment of deficiency states in adults. The determination (n. 48/2023) was published yesterday in the Official Journal, informs the national regulatory body.
“The update of the Note, established in 2019 – explains Aifa – was necessary following the publication of new scientific evidence which further clarified the role of vitamin D in the absence of concomitant risk conditions”. In particular, “the results of two large randomized clinical trials” were taken into consideration, the American Vital study (Nejm 2022) and the European Do-Health study (Jama 2020).
“Both – recalls the agency – have concluded that supplementation with more than adequate doses of vitamin D (2000 IU day of cholecalciferol) and for several years (over 5 years in the first study and 3 years in the second) it is not able to modify the risk of fracture in the healthy population, without risk factors for osteoporosis. These results were also confirmed among subjects with lower levels of vitamin 25(OH)D. To these main studies is added – specifies Aifa – the rich literature on use in Covid-19, which has not demonstrated any benefit of vitamin D even in this condition”.
“On this occasion, some improved clarifications were included in the text of the Note, on the proposal of clinicians or scientific societies”, reports AIFA.
These, the Italian Medicines Agency details, are the amendments to Note 96: “Introduction of the new risk category ‘persons with severe motor impairment or bedridden who live at home’; reduction from 20 to 12 ng/mL (or from 50 at 30 nmol/L) of the maximum level of serum vitamin 25(OH)D, in the presence or absence of specific symptoms and in the absence of other associated risk conditions, necessary for reimbursement purposes; specification of differentiated levels of vitamin 25(OH) )D serum in the presence of certain risk conditions (e.g. malabsorption disease, hyperparathyroidism) already present in the first version of the Note; update of the paragraph relating to the most recent evidence mentioned above and insertion of a short paragraph dedicated to vitamin D and Covid-19 19; introduction of a paragraph on the potential risks associated with the improper use of vitamin D preparations”.