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[The effect of administration of dietary supplement with calcium and vitamins D3 and B6 on calcium homeostasis and falls incidence in patients with high fracture risk undergoing medical rehabilitation].

Elimination of vitamin D and calcium deficiencies is of particular importance in older patients undergoing medical rehabilitation after a serious illness, surgery or injury and having a high risk of fractures. Preventing falls and fractures, including during the course of rehabilitation, is an important challenge that can be addressed in these patients, in particular through improved nutrition and vitamin D and calcium supplementation. The aim of the study was to evaluate the effect of long-term intake of a complex dietary supplement with calcium and vitamins D3 and B6 on calcium homeostasis and the frequency of falls in patients with high fracture risk undergoing medical rehabilitation. Material and methods. The study enrolled 109 women and 10 men (mean age 65.5±7.9 years) with high fracture risk who were undergoing medical rehabilitation. After baseline examination, 41 patients have been receiving antiresorptive therapy already comprised group 1, and patients who didn't receive osteoporotic therapy were randomized into groups 2 (n=39) and 3 (control, n=39). Patients in groups 1 and 2 for 12 months were prescribed a dietary supplement containing calcium in a daily dose of 200 mg (in the form of citrate 1000 mg), 600 IU of vitamin D3 and 2 mg of vitamin B6. All patients underwent assessment of bone mineral density (BMD), calculation of absolute 10-year fracture risk according to FRAX, assessment of food calcium intake, etermination of biochemical parameters of calcium-phosphorus metabolism and bone remodeling (total calcium, inorganic phosphorus, alkaline phosphatase activity - by colorimetric method in blood serum; immunoreactive parathyroid hormone (PTH) and osteocalcin - by electrochemiluminescence immunoassay in blood serum; β-isomer of C-terminal telopeptide of type I collagen (CTx) and 25(OH)D in blood plasma - by immunochemiluminescence analysis), cases of falls and fractures were fixed. Results. Average daily intake of calcium in the studied sample (n=119) was 782.9±243.4 mg, and 67.2% of patients consumed less than 800 mg of calcium daily. Vitamin D deficit was detected in 38.4% of the examined, its insufficiency - in 32.8%. An increase in 25(OH)D concentration was noted in groups 1 and 2 after 6 and 12 months (p<0.01), while in group 3 there was no dynamics of 25(OH)D (p>0.05). Patients in group 1 showed an increase in the level of osteocalcin and total calcium after 6 and 12 months, as well as alkaline phosphatase activity after 6 months (p<0.05). In group 3, there was an increase of PTH levels after 6 (p<0.05) and 12 months (p<0.01), CTx and alkaline phosphatase activity after 12 months (p<0.05). In group 1, there was an increase in BMD in the spine (+4.2%, p=0.024), femoral neck (+3.0%, p=0.041), and total femur (+2.7%, p=0.045), in patients of group 2 - an increase in BMD in the spine (+1.8%, p=0.048). In group 1, there was also a decrease in proportion of patients who fell after 6 months (χ2=4.97, p=0.026) and a decrease in the total number of falls after 12 months (χ2=4.89, p=0.027). Group 2 showed a decrease in the number of patients who fell after 6 and 12 months (χ2=48.58, p=0.0034 at both stages of the study) and the number of falls in general after 6 months (χ2=6.02, p=0.0142). Conclusion. The obtained data allow us to recommend prescription of dietary supplements containing calcium and vitamin D3 as a part of complex rehabilitation of patients with high fracture risk.