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Effects of supplementation with cholecalciferol on bone tissue and inflammation in patients with pre-dialysis chronic kidney disease

Grant number: 09/52144-0
Support type:Regular Research Grants
Duration: April 01, 2010 - May 31, 2012
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Aluízio Barbosa de Carvalho
Grantee:Aluízio Barbosa de Carvalho
Home Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil


Disturbances in the calcium, phosphorus and parathormone metabolism are frequent in chronic kidney disease, resulting from decreased renal mass and the synthesis of 1, 25-dihydroxy vitamin D (calcitriol). The calcitriol drift of 25-hydroxy vitamin D (calcidiol), which is derived from the pro-vitamin D, ergocalciterol and cholecalciferol. It maintains the calcium homeostasis and also has immunomodulatory effects. The objective of this study is to investigate the effects of restoring the levels of vitamin D on bone histological changes and inflammatory status of patients with chronic kidney disease in pre-dialysis phase. This is a prospective, randomized, double blind study, complementary to the study "Effects of supplementation with cholecalciferol on bone mineral metabolism in patients with chronic kidney disease" (FAPESP No 2006/03811-6), in which 100 adult patients with chronic kidney disease in stages 3 and 4 and with vitamin D insufficiency (calcidiol between 15 and 30 ng / mL) are randomized to vitamin D group (supplementation with 50,000 IU / month of cholecalciferol) and control group (placebo). Patients deficient in vitamin D (calcidiol <15ng/mL) are treated with 50,000 IU / week of cholecalciferol. The current proposal is to study a subgroup of patients with insufficient vitamin D (n = 25 in each group), and defficient patients (n=25), totaling 75 patients to be submitted to bone densitometry and bone biopsy for histomorphometric analysis, at the beginning and after 18 months of follow up, besides biochemical tests, hormonal and regular inflammatory markers. The expected results are the normalization of the levels of calcidiol, reduction of the inflammatory state and improvement of bone metabolism. (AU)