VITA-D: Cholecalciferol substitution in vitamin D deficient kidney transplant recipients: A randomized, placebo-controlled study to evaluate the post-transplant outcome

Trials

Volumn 10, Issue , 2009, Pages

  Thiem, Ursula ^a   Heinze, Georg ^a   Segel, Rudolf ^b   Perkmann, Thomas ^a   Kainberger, Franz ^a   Mühlbacher, Ferdinand ^a   Hörl, Walter ^a   Borchhardt, Kyra ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b UNIVERSITY OF VIENNA   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; COLECALCIFEROL; MONOCLONAL ANTIBODY; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; OLEOVIT D3 DROP; PLACEBO; POLYCLONAL ANTIBODY; PREDNISONE; STEROID; TACROLIMUS; UNCLASSIFIED DRUG; VITAMIN D; IMMUNOLOGIC FACTOR; VITAMIN;

ACUTE GRAFT REJECTION; ARTICLE; BONE DENSITY; CALCIUM HOMEOSTASIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DUAL ENERGY X RAY ABSORPTIOMETRY; FOLLOW UP; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; HUMAN; IMMUNOLOGICAL TOLERANCE; IMMUNOMODULATION; INCIDENCE; INFECTION RATE; KIDNEY GRAFT; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PARALLEL DESIGN; POSTOPERATIVE PERIOD; PREVALENCE; RANDOMIZED CONTROLLED TRIAL; RENAL PROTECTION; TREATMENT DURATION; VITAMIN D DEFICIENCY; DRUG EFFECT; GRAFT REJECTION; GRAFT SURVIVAL; METHODOLOGY; ORAL DRUG ADMINISTRATION; RISK ASSESSMENT; TIME; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; CHOLECALCIFEROL; DOUBLE-BLIND METHOD; GLOMERULAR FILTRATION RATE; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOLOGIC FACTORS; KIDNEY TRANSPLANTATION; RESEARCH DESIGN; RISK ASSESSMENT; TIME FACTORS; TREATMENT OUTCOME; VITAMIN D DEFICIENCY; VITAMINS;

EID: 67649976964     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-10-36     Document Type: Article

References (48)

1. Dusso AS Brown AJ Slatopolsky E Vitamin D Am J Physiol Renal Physiol 2005, 289:F8-28. 10.1152/ajprenal.00336.2004 15951480
2. Zittermann A Vitamin D in preventive medicine: Are we ignoring the evidence? Br J Nutr 2003, 89:552-572. 10.1079/BJN2003837 12720576
3. Holick MF Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and cardiovascular disease Am J Clin Nutr 2004, 80:1678S-1688S. 15585788
4. Thomas MK Lloyd-Jones DM Thadhani RI Shaw AC Deraska DJ Kitch BT Vamvakas EC Dick IM Prince RL Finkelstein JS Hypovitaminosis D in medical inpatients N Engl J Med 1998, 338:777-783. 10.1056/ NEJM199803193381201 9504937
5. Wielen van der RP Lowik MR Berg van den H de Groot LC Haller J Moreiras O van Staveren WA Serum vitamin D concentrations among elderly people in Europe Lancet 1995, 346:207-210. 10.1016/S0140-6736(95)91266-5 7616799
6. LaClair RE Hellman RN Karp SL Kraus M Ofner S Li Q Graves KL Moe SM Prevalence of calcidiol deficiency in CKD: A cross-sectional study across latitudes in the United States Am J Kidney Dis 2005, 45:1026-1033. 10.1053/j.ajkd.2005.02.029 15957131
7. Gonzalez EA Sachdeva A Oliver DA Martin KJ Vitamin D insufficiency and deficiency in chronic kidney disease. A single center observational study Am J Nephrol 2004, 24:503-510. 10.1159/000081023 15452403
8. Ducloux D Courivaud C Bamoulid J Kazory A Dumoulin G Chalopin JM Pretransplant serum vitamin D levels and risk of cancer after renal transplantation Transplantation 2008, 85:1755-1759. 10.1097/ TP.0b013e318172cb2c 18580467.
9. Sadlier DM Magee CC Prevalence of 25(OH) vitamin D (calcidiol) deficiency at time of renal transplantation: A prospective study Clin Transplant 2007, 21:683-688. 17988259
10. Euvrard S Kanitakis J Claudy A Skin cancers after organ transplantation N Engl J Med 2003, 348:1681-1691. 10.1056/NEJMra022137 12711744
11. Lynch IT Eustace JA Plant WD Cashman KD O'Keefe M Lordan S Moloney R Inadequate dietary calcium and vitamin D intakes in renal-transplant recipients in Ireland J Ren Nutr 2007, 17:408-415. 10.1053/ j.jrn.2007.05.005 17971313
12. Querings K Girndt M Geisel J Georg T Tilgen W Reichrath J 25-hydroxyvitamin D deficiency in renal transplant recipients J Clin Endocrinol Metab 2006, 91:526-529. 10.1210/jc.2005-0547 16303843
13. Stavroulopoulos A Cassidy MJ Porter CJ Hosking DJ Roe SD Vitamin D status in renal transplant recipients Am J Transplant 2007, 7:2546-2552. 10.1111/j.1600-6143.2007.01978.x 17908281
14. Holick MF Vitamin D for health and in chronic kidney disease Semin Dial 2005, 18:266-275. 10.1111/j.1525-139X.2005.18402.x 16076348
15. Mathieu C Adorini L The coming of age of 1,25-dihydroxyvitamin D(3) analogs as immunomodulatory agents Trends Mol Med 2002, 8:174-179. 10.1016/S1471-4914(02)02294-3 11927275
16. Bikle D Nonclassic Actions of Vitamin D J Clin Endocrinol Metab 2008, 94:26-34. 10.1210/jc.2008-1454 18854395
17. Mathieu C Jafari M Immunomodulation by 1,25-dihydroxyvitamin D3: therapeutic implications in hemodialysis and renal transplantation Clin Nephrol 2006, 66:275-283. 17063995
18. Laaksi I Ruohola JP Tuohimaa P Auvinen A Haataja R Pihlajamaki H Ylikomi T An association of serum vitamin D concentrations < 40 nmol/L with acute respiratory tract infection in young Finnish men Am J Clin Nutr 2007, 86:714-717. 17823437
19. Muhe L Lulseged S Mason KE Simoes EA Case-control study of the role of nutritional rickets in the risk of developing pneumonia in Ethiopian children Lancet 1997, 349:1801-1804. 10.1016/S0140-6736(96)12098-5 9269215
20. van Etten E Mathieu C Immunoregulation by 1,25-dihydroxyvitamin D3: basic concepts J Steroid Biochem Mol Biol 2005, 97:93-101. 10.1016/ j.jsbmb.2005.06.002 16046118
21. Boonstra A Barrat FJ Crain C Heath VL Savelkoul HF O'Garra A 1alpha,25-Dihydroxyvitamin d3 has a direct effect on naive CD4(+) T cells to enhance the development of Th2 cells J Immunol 2001, 167:4974-4980. 11673504
22. Penna G Adorini L 1 Alpha, 25-dihydroxyvitamin D3 inhibits differentiation, maturation, activation, and survival of dendritic cells leading to impaired alloreactive T cell activation J Immunol 2000, 164:2405-2411. 10679076
23. Adorini L Penna G Giarratana N Roncari A Amuchastegui S Daniel KC Uskokovic M Dendritic cells as key targets for immunomodulation by Vitamin D receptor ligands J Steroid Biochem Mol Biol 2004, 89-90:437-441. 10.1016/j.jsbmb.2004.03.013
24. Gregori S Casorati M Amuchastegui S Smiroldo S Davalli AM Adorini L Regulatory T cells induced by 1 alpha,25-dihydroxyvitamin D3 and mycophenolate mofetil treatment mediate transplantation tolerance J Immunol 2001, 167:1945-1953. 11489974
25. Becker BN Hullett DA O'Herrin JK Malin G Sollinger HW DeLuca H Vitamin D as immunomodulatory therapy for kidney transplantation Transplantation 2002M 74:1204-1206. 10.1097/00007890-200210270-00030 12438976
26. O'Herrin JK Hullett DA Heisey DM Sollinger HW Becker BN A retrospective evaluation of 1,25-dihydroxyvitamin D(3) and its potential effects on renal allograft function Am J Nephrol 2002, 22:515-520. 10.1159/ 000065289 12381953
27. Tanaci N Karakose H Guvener N Tutuncu NB Colak T Haberal M Influence of 1,25-dihydroxyvitamin D3 as an immunomodulator in renal transplant recipients: A retrospective cohort study Transplant Proc 2003, 35:2885-2887. 10.1016/j.transproceed.2003.10.014 14697928
28. Sezer S Uyar M Arat Z Ozdemir FN Haberal M Potential effects of 1,25-dihydroxyvitamin D3 in renal transplant recipients Transplant Proc 2005, 37:3109-3111. 10.1016/j.transproceed.2005.07.026 16213322
29. Uyar M Sezer S Arat Z Elsurer R Ozdemir FN Haberal M 1,25-dihydroxyvitamin D(3) therapy is protective for renal function and prevents hyperparathyroidism in renal allograft recipients Transplant Proc 2006, 38:2069-2073. 10.1016/j.transproceed.2006.06.051 16980002
30. Ardalan MR Maljaei H Shoja MM Piri AR Khosroshahi HT Noshad H Argani H Calcitriol started in the donor, expands the population of CD4+CD25+ T cells in renal transplant recipients Transplant Proc 2007, 39:951-953. 10.1016/j.transproceed.2007.04.012 17524860
31. Ruster C Wolf G Renin-angiotensin-aldosterone system and progression of renal disease J Am Soc Nephrol 2006, 17:2985-2991. 10.1681/ ASN.2006040356 17035613
32. Wolf G Renal injury due to renin-angiotensin-aldosterone system activation of the transforming growth factor-beta pathway Kidney Int 2006, 70:1914-1919. 16985515
33. Li YC Kong J Wei M Chen ZF Liu SQ Cao LP 1,25-Dihydroxyvitamin D(3) is a negative endocrine regulator of the renin-angiotensin system J Clin Invest 2002, 110:229-238. 151055 12122115
34. Freundlich M Quiroz Y Zhang Z Zhang Y Bravo Y Weisinger JR Li YC Rodriguez-Iturbe B Suppression of renin-angiotensin gene expression in the kidney by paricalcitol Kidney Int 2008, 4:1394-402. 10.1038/ ki.2008.408
35. Schwarz U Amann K Orth SR Simonaviciene A Wessels S Ritz E Effect of 1,25 (OH)2 vitamin D3 on glomerulosclerosis in subtotally nephrectomized rats Kidney Int 1998, 53:1696-1705. 10.1046/j.1523-1755.1998.00951.x 9607202
36. Makibayashi K Tatematsu M Hirata M Fukushima N Kusano K Ohashi S Abe H Kuze K Fukatsu A Kita T Doi T A vitamin D analog ameliorates glomerular injury on rat glomerulonephritis Am J Pathol 2001, 158:1733-1741. 11337371
37. Kuhlmann A Haas CS Gross ML Reulbach U Holzinger M Schwarz U Ritz E Amann K 1,25-Dihydroxyvitamin D3 decreases podocyte loss and podocyte hypertrophy in the subtotally nephrectomized rat Am J Physiol Renal Physiol 2004, 286:F526-533. 10.1152/ajprenal.00316.2003 14600034
38. Piecha G Kokeny G Nakagawa K Koleganova N Geldyyev A Berger I Ritz E Schmitt CP Gross ML Calcimimetic R-568 or calcitriol: Equally beneficial on progression of renal damage in subtotally nephrectomized rats Am J Physiol Renal Physiol 2008, 294:F748-757. 10.1152/ajprenal.00220.2007 18199601
39. Agarwal R Acharya M Tian J Hippensteel RL Melnick JZ Qiu P Williams L Batlle D Antiproteinuric effect of oral paricalcitol in chronic kidney disease Kidney Int 2005, 68:2823-2828. 10.1111/j.1523-1755.2005.00755.x 16316359
40. Racusen LC Solez K Colvin RB Bonsib SM Castro MC Cavallo T Croker BP Demetris AJ Drachenberg CB Fogo AB et al The Banff 97 working classification of renal allograft pathology Kidney Int 1999, 55:713-723. 10.1046/j.1523-1755.1999.00299.x 9987096
41. Aschenbrenner JK Sollinger HW Becker BN Hullett DA 1,25-(OH(2))D(3) alters the transforming growth factor beta signaling pathway in renal tissue J Surg Res 2001, 100:171-175. 10.1006/jsre.2001.6221 11592788
42. Hullett DA Laeseke PF Malin G Nessel R Sollinger HW Becker BN Prevention of chronic allograft nephropathy with vitamin D Transpl Int 2005, 18:1175-1186. 10.1111/j.1432-2277.2005.00187.x 16162105
43. Harris S Coupes BM Roberts SA Roberts IS Short CD Brenchley PE TGF-beta1 in chronic allograft nephropathy following renal transplantation J Nephrol 2007, 20:177-185. 17514622
44. Casez JP Lippuner K Horber FF Montandon A Jaeger P Changes in bone mineral density over 18 months following kidney transplantation: The respective roles of prednisone and parathyroid hormone Nephrol Dial Transplant 2002, 17:1318-1326. 10.1093/ndt/17.7.1318 12105258
45. Geller NL Pocock SJ Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners Biometrics 1987, 43:213-223. 10.2307/2531962 3567306
46. Holick MF Vitamin D deficiency N Engl J Med 2007, 357:266-281. 10.1056/ NEJMra070553 17634462
47. Vieth R Vitamin D toxicity, policy, and science J Bone Miner Res 2007, 22(Suppl 2):V64-68. 10.1359/jbmr.07s221 18290725
48. Hathcock JN Shao A Vieth R Heaney R Risk assessment for vitamin D Am J Clin Nutr 2007, 85:6-18. 17209171