Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA Note 96 'Prevention and treatment of vitamin D deficiency' has been updated - AIFA Note 96 'Prevention and treatment of vitamin D deficiency' has been updated

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AIFA Note 96 'Prevention and treatment of vitamin D deficiency' has been updated

The Italian Medicines Agency has updated Note 96 (AIFA Resolution No. 48/2023 published in the Official Gazette No. XX of 20 February 2023) on the criteria of prescribing appropriateness of supplementation with vitamin D and its analogues (cholecalciferol, calcifediol) for prevention and treatment of deficiency states in adults.

The update of the Note, established in 2019, 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 (LeBoff M et al, NEJM 2022) and the European study DO-HEALTH (Bischoff-Ferrari HA et al, JAMA 2020). Both studies concluded that supplementation with more than adequate doses of vitamin D (2000 IU per day of cholecalciferol) and for several years (over 5 years in the first study and 3 years in the second) is unable 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.

In addition to these main studies, there is the extensive literature concerning the use in COVID-19, which has shown no benefit of vitamin D in this condition as well.

On this occasion, some improvements have been included in the text of the Note on the proposal of clinicians or scientific societies.

The changes introduced with the update of Note 96 are as follows:

  • introduction of the new risk category "persons with severe motor impairments or bedridden persons living at home";
  • reduction from 20 to 12 ng/mL (or from 50 to 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, required for the purposes of reimbursement;
  • specification of differentiated levels of serum vitamin 25(OH)D in the presence of certain risk conditions (e.g. malabsorption disease, hyperparathyroidism) already present in the first version of the Note;
  • updating of the paragraph relating to the most recent evidence mentioned above and inclusion of a short paragraph on vitamin D and COVID-19;
  • introduction of a paragraph on the potential risks associated with the improper use of vitamin D preparations.

The updated Note 96 and its annex are available on the AIFA portal on the dedicated page.

Published on: 21 February 2023

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