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The principal investigator of VITALE, Dr Marie Courbebaisse (Paris, France), commented:
Our study shows that currently recommended doses of vitamin D are not sufficient to protect patients from the risk of fracture after a kidney transplant. This calls into question the recommendations of KDIGO's current international guidelines, which recommend the use of low doses of cholecalciferol similar to those recommended for the general population. "
Receivers of a kidney transplant are at increased risk of fracture due to a combination of factors. The kidneys can no longer maintain their normal levels of parathyroid hormone, vitamin D and calcium and phosphate in the blood, important factors for bone health. As a result, patients are likely to suffer from kidney disease called chronic kidney disease or bone mineral disease (CKD-MBD) at the time of transplantation. or they can develop the disease if their grafted kidney has a suboptimal function. Some immunosuppressive drugs, administered to prevent organ rejection, also have adverse effects on bone health. Current recommendations recommend that vitamin D deficiencies or deficiencies be corrected to improve bone health, in accordance with recommendations in the general population. However, high-level evidence to support this recommendation was lacking.
Vitamin D (cholecalciferol) is the form of vitamin D naturally produced by the body when exposed to direct sunlight. The purpose of the VITALE study was to compare transplantation. A prospective multicenter, double-blind, VITALE-controlled trial randomly badigned 536 kidney transplant recipients (mean age 50.8 years, 335 men) to 100,000 IU (high dose) or 12,000 IU (low dose) cholecalciferol every two weeks. for two months, then monthly for 22 months. In the study, "low doses" corresponded to a recommended minimum of 400 IU / day.
After 24 months, vitamin D levels were significantly higher in the high-dose group than in the low-dose group: 43.1 (12.8) ng / mL versus 25.1 (7.4) ng / mL against 20.2 (8.1) vs 19.2 (7.0) ng / ml at the inclusion of the study (p <0.0001). The incidence of fractures was significantly lower in the high dose group (1% versus 4% in the low dose group, p = 0.02). There was, however, no difference between the two groups with regard to the risks of diabetes, major cardiac events (eg heart attack), new cases of cancer or death. The high dose treatment was well tolerated with no increased risk of vascular calcification or abnormal levels of calcium and phosphate in the blood (hypercalcemia and hyperphosphatemia, respectively).
Professor Carmine Zoccali, President of ERA-EDTA, concluded:
The VITALE study is important for nephrologists and their patients because it shows that a high dose of vitamin D is an effective way to reduce the fracture rate after a kidney transplant, with a very low risk of side effects. More generally, we find again that other benefits of vitamin D observed in observational studies are not taken into account when supplementation is tested in randomized controlled trials. "
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